Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070828
Company: SANDOZ
Company: SANDOZ
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 |
---|---|---|---|---|---|---|---|
05/15/1986 | 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-14 | Labeling-Package Insert |
Label is not available on this site. |
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05/09/2001 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/13/1995 | SUPPL-6 | Labeling |
Label is not available on this site. |
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03/01/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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08/19/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
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05/01/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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01/17/1989 | SUPPL-2 | Labeling |
Label is not available on this site. |