Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089068
Company: ALCON PHARMS LTD
Company: ALCON PHARMS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SULFACETAMIDE SODIUM | SULFACETAMIDE SODIUM | 30% | SOLUTION/DROPS;OPHTHALMIC | 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 |
---|---|---|---|---|---|---|---|
05/05/1987 | 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 |
---|---|---|---|---|---|
02/19/1999 | SUPPL-13 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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02/02/1999 | SUPPL-11 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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12/04/1996 | SUPPL-10 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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04/16/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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05/08/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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05/17/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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03/27/1989 | SUPPL-3 | Labeling |
Label is not available on this site. |
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10/28/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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10/28/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |