Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070338
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE | 25MG;4MG | TABLET; ORAL | Prescription | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 11/10/1988 | 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 |
|---|---|---|---|---|---|
| 05/07/2002 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 02/25/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/05/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/04/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/28/1995 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 10/05/1993 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 09/01/1993 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 10/22/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/05/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/31/1990 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |