Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088883
Company: PLIVA
Company: PLIVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/26/1984 | 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 |
|---|---|---|---|---|---|
| 06/25/2001 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 10/05/2000 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 07/07/2000 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/24/1995 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 07/14/1995 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 05/11/1994 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/04/1993 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 05/26/1992 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 07/29/1991 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/22/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/14/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/14/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/14/1985 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |