Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089423
Company: MUTUAL PHARM
Company: MUTUAL PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 02/17/1987 | 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 |
|---|---|---|---|---|---|
| 12/01/1998 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/16/1995 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 12/23/1994 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/1994 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/03/1993 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/31/1992 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 12/30/1991 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 05/01/1991 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/01/1991 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/01/1991 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/01/1991 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/28/1990 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/14/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/12/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/27/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |