Drugs@FDA: FDA-Approved Drugs
Company: SUN PHARM INDUSTRIES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TEMAZEPAM | TEMAZEPAM | 15MG | 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 |
---|---|---|---|---|---|---|---|
07/10/1986 | 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 |
---|---|---|---|---|---|
05/26/2021 | SUPPL-26 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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08/12/2019 | SUPPL-25 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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08/12/2019 | SUPPL-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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02/04/2011 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
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09/14/2009 | SUPPL-20 | Labeling |
Label is not available on this site. |
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12/01/1998 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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12/23/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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10/05/1993 | SUPPL-12 | Labeling |
Label is not available on this site. |
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04/03/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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04/03/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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03/01/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
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05/31/1990 | SUPPL-7 | Bioequivalence |
Label is not available on this site. |
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01/27/1989 | SUPPL-4 | Labeling |
Label is not available on this site. |
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04/01/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |