Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
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 |
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. |
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 |