Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072164
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MAPROTILINE HYDROCHLORIDE | MAPROTILINE 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 |
|---|---|---|---|---|---|---|---|
| 06/01/1988 | 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 |
|---|---|---|---|---|---|
| 07/17/2014 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/07/2002 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/10/1999 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/26/1998 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 06/04/1992 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 05/20/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 11/29/1990 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 05/15/1989 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |