Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071654
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG 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 |
|---|---|---|---|---|---|---|---|
| 02/18/1988 | 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-13 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/01/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/06/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 09/26/1995 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 12/23/1994 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/11/1994 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/01/1993 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |