Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 086945
Company: SANDOZ

Products on ANDA 086945

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	AA	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 086945

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/20/1983	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/86945ap.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/31/2017	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
12/06/2012	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
12/06/2012	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
11/13/2002	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
01/11/2001	SUPPL-18	Manufacturing (CMC)-Facility		Label is not available on this site.
02/02/2000	SUPPL-17	Manufacturing (CMC)-Facility		Label is not available on this site.
09/24/1998	SUPPL-16	Labeling		Label is not available on this site.
08/10/1998	SUPPL-15	Labeling		Label is not available on this site.
04/30/1998	SUPPL-14	Labeling		Label is not available on this site.
04/12/1996	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
01/16/1997	SUPPL-12	Labeling		Label is not available on this site.
01/22/1993	SUPPL-11	Labeling		Label is not available on this site.
10/27/1992	SUPPL-10	Labeling		Label is not available on this site.
01/16/1997	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
12/19/1994	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
10/26/1989	SUPPL-7	Labeling		Label is not available on this site.
04/12/1988	SUPPL-6	Labeling		Label is not available on this site.
06/12/1985	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
01/30/1985	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 086945

PHENTERMINE HYDROCHLORIDE

CAPSULE;ORAL; 30MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	No	AA	204318	AUROLIFE PHARMA LLC
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	No	AA	202248	ELITE LABS
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	No	AA	040875	KVK TECH
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	No	AA	040886	KVK TECH
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	No	AA	205019	NUVO PHARM
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	Yes	AA	086945	SANDOZ
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	Yes	AA	087190	SANDOZ