Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201961
Company: LANNETT CO INC
Company: LANNETT CO INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 37.5MG | CAPSULE;ORAL | Prescription | AA | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/20/2011 | ORIG-1 | Approval | Not Applicable |
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-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/05/2012 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/20/2012 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/14/2012 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
PHENTERMINE HYDROCHLORIDE
CAPSULE;ORAL; 37.5MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ADIPEX-P | PHENTERMINE HYDROCHLORIDE | 37.5MG | CAPSULE;ORAL | Prescription | Yes | AA | 088023 | TEVA |
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 37.5MG | CAPSULE;ORAL | Prescription | No | AA | 040228 | ELITE LABS INC |
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 37.5MG | CAPSULE;ORAL | Prescription | No | AA | 202846 | INVAGEN PHARMS |
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 37.5MG | CAPSULE;ORAL | Prescription | No | AA | 040887 | KVK TECH |
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 37.5MG | CAPSULE;ORAL | Prescription | No | AA | 201961 | LANNETT CO INC |
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 37.5MG | CAPSULE;ORAL | Prescription | No | AA | 205017 | NUVO PHARM |
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