Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070454
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLURAZEPAM HYDROCHLORIDE | FLURAZEPAM HYDROCHLORIDE | 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 |
|---|---|---|---|---|---|---|---|
| 08/04/1986 | 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 |
|---|---|---|---|---|---|
| 01/17/2023 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/08/2021 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/06/2019 | SUPPL-19 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1994 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/17/1993 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/07/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/01/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 12/22/1987 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/27/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/08/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/13/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/13/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/13/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |