Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072987
Company: WATSON LABS TEVA
Company: WATSON LABS TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 03/29/1991 | 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-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/19/2001 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 04/12/2001 | SUPPL-15 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 03/21/2000 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 05/18/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/19/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/08/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/16/1996 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 12/31/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/31/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/25/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/25/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/27/1993 | SUPPL-2 | Labeling |
Label is not available on this site. |