Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080029
Company: PADAGIS US
Company: PADAGIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SULFACETAMIDE SODIUM | SULFACETAMIDE SODIUM | 10% | OINTMENT;OPHTHALMIC | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/22/1971 | 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 |
|---|---|---|---|---|---|
| 03/07/1996 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/1995 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/27/1995 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/03/1995 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/03/1995 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/19/1995 | SUPPL-32 | Labeling |
Label is not available on this site. |
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| 03/13/1995 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/14/1993 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 05/02/1991 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/19/1989 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 03/25/1988 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 08/01/1983 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/08/1982 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |