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Phentermine Approval History by Formulation
This file was meant as an alternative downloadable resource and was not originally created by us. Cited sources of the original can be found at the end of the file.
1959 - May 4: New molecular entity (NME)
IONAMIN CAPSULE, EXTENDED RELEASE; ORAL
(EQ 30MG BASE, EQ 15MG BASE)
Active Ingredient(s): PHENTERMINE RESIN COMPLEX Applicant: UCB INC Chemical Type: New molecular entity (NME) Marketing status: Discontinued
1973 - August 14: New formulation
FASTIN CAPSULE; ORAL (30MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: GLAXOSMITHKLINE Chemical Type: New formulation Marketing status: Discontinued
1976 - July 11
PHENTERMINE HYDROCHLORIDE TABLET; ORAL (8MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: TG UNITED LABS Marketing status: Discontinued
1977 - March 14
PHENTERMINE HYDROCHLORIDE TABLET; ORAL (8MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: TG UNITED LABS Marketing status: Discontinued
1978 - April 28
PHENTERMINE HYDROCHLORIDE TABLET; ORAL (8MG, 8MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: SANDOZ Marketing status: Discontinued
1980 - March 24
ONA-MAST TABLET; ORAL (8MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: MAST MM Marketing status: Discontinued
1980 - September 10
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL
(30MG, 30MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: TG UNITED LABS Marketing status: Discontinued
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL (15MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: CAMALL Marketing status: Discontinued
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL (30MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: ABC HOLDING Marketing status: Discontinued
1980 - October 22
ADIPEX-P TABLET; ORAL
(37.5MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: TEVA Marketing status: Prescription
1981 - April 3
ONA-MAST CAPSULE; ORAL (30MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: MAST MM Marketing status: Discontinued
1981 - June 12
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL (30MG, 15MG, 30MG, 30MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: SANDOZ Marketing status: Prescription
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL (15MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: SANDOZ Marketing status: Discontinued
1981 - September 17
ONA-MAST CAPSULE; ORAL (30MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: MAST MM Marketing status: Discontinued
1982 - March 18
OBY-TRIM CAPSULE; ORAL
(30MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: SHIRE RICHWOOD Marketing status: Discontinued
1982 - April 9
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL
(30MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: USL PHARMA Marketing status: Discontinued
1982 - December 6
PHENTERMINE HYDROCHLORIDE TABLET; ORAL (37.5MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: TG UNITED LABS Marketing status: Discontinued
1983 - February 3
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL (30MG, 15MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: LANNETT Marketing status: Prescription
1983 - July 20
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL (30MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: SANDOZ
Marketing status: Prescription
1983 - August 2
ADIPEX-P CAPSULE; ORAL (37.5MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: TEVA Marketing status: Prescription
1983 - October 14
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL(37.5MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: TG UNITED LABS Marketing status: Discontinued
1983 - October 19
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL(37.5MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Marketing status: Discontinued
1983 - December 22
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL(37.5MG, 37.5MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: TG UNITED LABS Marketing status: Discontinued
1984 - March 27
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL (30MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: USL PHARMA Marketing status: Discontinued
1984 - April 4
PHENTERMINE HYDROCHLORIDE TABLET; ORAL (37.5MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: TG UNITED LABS
Marketing status: Discontinued
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL (30MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: TEVA Marketing status: Discontinued
1984 - April 9
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL (30MG, 30MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: TEVA Marketing status: Discontinued
1984 - May 23
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL(18.75MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: TG UNITED LABS Marketing status: Discontinued
1984 - June 4
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL(37.5MG, 37.5MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: TG UNITED LABS Marketing status: Discontinued 1984 - August 23
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL(37.5MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: TG UNITED LABS Marketing status: Discontinued
1984 - December 10
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL (30MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: USL PHARMA Marketing status: Discontinued
1985 - March 21
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL (30MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: WATSON LABS Marketing status: Discontinued
1985 - July 17
PHENTERMINE HYDROCHLORIDE TABLET; ORAL (37.5MG, 37.5MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: USL PHARMA Marketing status: Discontinued
1985 - November 1
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL (30MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: TEVA Marketing status: Discontinued
1986 - April 25
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL (30MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: DURAMED PHARMS BARR Marketing status: Discontinued
1987 - September 28
PHENTERMINE HYDROCHLORIDE TABLET; ORAL (30MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: SANDOZ INC Marketing status: Discontinued
1988 - February 4
PHENTERMINE RESIN 30 CAPSULE, EXTENDED RELEASE; ORAL (EQ 30MG BASE)
Active Ingredient(s): PHENTERMINE RESIN COMPLEX Applicant: QUANTUM PHARMICS 1997 - March 7
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL
(30MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: TG UNITED INC Marketing status: Discontinued
1997 - May 30
PHENTERMINE HYDROCHLORIDE TABLET; ORAL (37.5MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: MIKAH PHARMA Marketing status: Discontinued
1997 - June 18
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL (30MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: MIKAH PHARMA Marketing status: Discontinued
1997 - June 19
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL(37.5MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: MIKAH PHARMA Marketing status: Discontinued
1998 - November 25
PHENTERMINE HYDROCHLORIDE TABLET; ORAL (37.5MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: ACTAVIS ELIZABETH Marketing status: Prescription
2001 - August 30
PHENTERMINE HYDROCHLORIDE TABLET; ORAL (37.5MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: ABLE Marketing status: Discontinued
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL (30MG, 30MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: ABLE Marketing status: Discontinued
2001 - August 30
PHENTERMINE RESIN; ORAL (15, 30, 45MG)
Active Ingredient(s): PHENTERMINE ION EXCHANGE RESIN COMPLEX
Applicant: 3M PHARMS

Marketing status: Prescription

2002 - January 4
PHENTERMINE HYDROCHLORIDE TABLET; ORAL (37.5MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: VINTAGE PHARMS Marketing status: Prescription
2003 - January 14
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL (15MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: MIKAH PHARMA 2003 - January 22
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL
(30MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: MIKAH PHARMA Marketing status: Discontinued
2003 - March 13
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL (15MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: ABLE Marketing status: Discontinued
2003 - October 23
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL
(37.5MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: MUTUAL PHARM Marketing status: Discontinued
PHENTERMINE HYDROCHLORIDE TABLET; ORAL (37.5MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: MUTUAL PHARM Marketing status: Prescription
2005 - April 15
PHENTERMINE HYDROCHLORIDE TABLET; ORAL (37.5MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: LANNETT Marketing status: Prescription
2007 - August 21
PHENTERMINE HYDROCHLORIDE TABLET; ORAL (37.5MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: CARACO Marketing status: Prescription
2008 - March 21
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL (30MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: KVK TECH Marketing status: Prescription
2008 - March 31
PHENTERMINE HYDROCHLORIDE TABLET; ORAL (37.5MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: KVK TECH Marketing status: Prescription
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL (30MG, 15MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: KVK TECH Marketing status: Prescription
2008 - April 24
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL(37.5MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE

2009 - August 31
PHENTERMINE HYDROCHLORIDE TABLET; ORAL (37.5MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: BARR Marketing status: Prescription
2010 - March 18
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL (15MG, 30MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: BARR Marketing status: Prescription
2010 - July 16
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL (30MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: LANNETT Marketing status: Prescription
2011 - January 31
PHENTERMINE HYDROCHLORIDE TABLET; ORAL (37.5MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: ELITE LABS Marketing status: Prescription 2011 - June 13 - New formulation
SUPRENZA TABLET, ORALLY DISINTEGRATING; ORAL(37.5MG, 15MG, 30MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: CITIUS PHARMS Chemical Type: New formulation Marketing status: Prescription
2011 - July 20
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL(37.5MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: LANNETT HOLDINGS INC Marketing status: Prescription
2011 - July 28
PHENTERMINE RESIN COMPLEX CAPSULE, EXTENDED RELEASE; ORAL (EQ 15MG BASE, EQ 30MG BASE)
Active Ingredient(s): PHENTERMINE RESIN COMPLEX
Applicant: LANNETT HOLDINGS INC Marketing status: Prescription
2012 - March 27 - New formulation
SUPRENZA TABLET, ORALLY DISINTEGRATING; ORAL(30MG, 37.5MG, 15MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: CITIUS PHARMS Chemical Type: New formulation Marketing status: Prescription
2012 - September 21
PHENTERMINE HYDROCHLORIDE TABLET; ORAL (37.5MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: MIRROR PHARMS Marketing status: Prescription
2012 - September 28
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL (15MG, 30MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Marketing status: Prescription
Date Unknown - New ester, new salt, or other non-covalent derivative
PHENTERMINE HYDROCHLORIDE TABLET; ORAL (8MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: IVAX PHARMS Marketing status: Discontinued PHENTERMINE HYDROCHLORIDE TABLET; ORAL (8MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: WATSON LABS Marketing status: Discontinued
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL (30MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: IVAX PHARMS Marketing status: Discontinued
PHENTERMINE HYDROCHLORIDE TABLET; ORAL (8MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: USL PHARMA Marketing status: Discontinued
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL (30MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: TEVA Marketing status: Discontinued
TORA TABLET; ORAL (8MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: SOLVAY Marketing status: Discontinued WILPO TABLET; ORAL (8MG **Federal Register determination that product was not discontinued or withdrawn for safety or
efficacy
reasons**) Active Ingredient(s): PHENTERMINE HYDROCHLORIDE Applicant: SANDOZ Chemical Type: New ester, new salt, or other noncovalent derivative Marketing status: Discontinued
OBESTIN-30 CAPSULE; ORAL (30MG)
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
Applicant: FERNDALE LABS Marketing status: Discontinued
SOURCES:
http://www.drugs.com/pro/phentermine.html

Source: http://duromines.com/files/PAH.pdf

Medication_administration_guidelines.rtf

Revised Aug 2004 SOUTHWEST SCHOOL CORPORATION MEDICATION ADMINISTRATION AT SCHOOL GUIDELINES The Purpose of administering medication at school is to help each student maintain an optimal state of health that enhances each student’s educational efforts. The intent of the following guidelines is to reduce the number of medications given at school, while providing safe

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