Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085743
Company: MUTUAL PHARM
Company: MUTUAL PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/11/1977 | 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-67 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/16/1995 | SUPPL-66 | Labeling |
Label is not available on this site. |
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| 12/23/1994 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/11/1994 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/03/1993 | SUPPL-63 | Labeling |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-60 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/31/1992 | SUPPL-59 | Labeling |
Label is not available on this site. |
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| 12/30/1991 | SUPPL-58 | Labeling |
Label is not available on this site. |
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| 02/28/1990 | SUPPL-57 | Labeling |
Label is not available on this site. |
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| 02/28/1990 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/29/1987 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/29/1987 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/29/1987 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/20/1987 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/27/1986 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/05/1986 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |