Drugs@FDA: FDA-Approved Drugs
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 08/02/1977 | 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 |
|---|---|---|---|---|---|
| 06/18/1997 | SUPPL-167 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/1995 | SUPPL-166 | Labeling |
Label is not available on this site. |
||
| 02/15/1995 | SUPPL-165 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/1995 | SUPPL-164 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/1994 | SUPPL-163 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/06/1994 | SUPPL-162 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/17/1994 | SUPPL-161 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/23/1994 | SUPPL-160 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/1993 | SUPPL-159 | Labeling |
Label is not available on this site. |
||
| 06/12/1992 | SUPPL-158 | Labeling |
Label is not available on this site. |
||
| 12/31/1991 | SUPPL-156 | Labeling |
Label is not available on this site. |
||
| 06/10/1992 | SUPPL-155 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1989 | SUPPL-153 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1988 | SUPPL-152 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1988 | SUPPL-151 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/30/1987 | SUPPL-149 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/04/1987 | SUPPL-148 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1987 | SUPPL-146 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/09/1986 | SUPPL-145 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/09/1986 | SUPPL-144 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/1986 | SUPPL-143 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/1986 | SUPPL-142 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1985 | SUPPL-140 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/11/1985 | SUPPL-139 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/21/1984 | SUPPL-138 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1985 | SUPPL-137 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/1984 | SUPPL-136 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/15/1984 | SUPPL-135 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/07/1982 | SUPPL-130 | Manufacturing (CMC) |
Label is not available on this site. |