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 |
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 15MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/12/1981 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/31/2017 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/06/2012 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/06/2012 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/15/2002 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/02/2000 | SUPPL-24 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 09/24/1998 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 08/10/1998 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 04/30/1998 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 04/12/1996 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/21/1995 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/19/1996 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/22/1993 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 12/19/1994 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/03/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 04/12/1988 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 01/30/1985 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/19/1985 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/10/1983 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/02/1983 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/02/1983 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/1982 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/1982 | SUPPL-1 | 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 |
CAPSULE;ORAL; 15MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE;ORAL | Prescription | No | AA | 204318 | AUROLIFE PHARMA LLC |
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE;ORAL | Prescription | No | AA | 202248 | ELITE LABS |
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE;ORAL | Prescription | No | AA | 040886 | KVK TECH |
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE;ORAL | Prescription | No | AA | 205019 | NUVO PHARM |
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE;ORAL | Prescription | Yes | AA | 087190 | SANDOZ |