Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074449
Company: BAUSCH AND LOMB
Company: BAUSCH AND LOMB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE | PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM | EQ 0.23% PHOSPHATE;10% | SOLUTION/DROPS;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 |
---|---|---|---|---|---|---|---|
12/29/1995 | 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 |
---|---|---|---|---|---|
11/27/2001 | SUPPL-11 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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04/30/2001 | SUPPL-10 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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03/07/2001 | SUPPL-9 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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06/27/2000 | SUPPL-8 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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04/28/2000 | SUPPL-7 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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05/18/2000 | SUPPL-6 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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06/07/1999 | SUPPL-5 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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05/28/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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04/30/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |