Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088994
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHENYLBUTAZONE | PHENYLBUTAZONE | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/04/1985 | 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 |
|---|---|---|---|---|---|
| 12/01/1998 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1994 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/11/1994 | SUPPL-13 | 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. |
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| 04/03/1992 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/20/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 06/28/1989 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 03/03/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/01/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/06/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/14/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |