Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 005963
Company: SCHERING
Company: SCHERING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM SULAMYD | SULFACETAMIDE SODIUM | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS;OPHTHALMIC | Discontinued | None | Yes | No |
SODIUM SULAMYD | SULFACETAMIDE SODIUM | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT;OPHTHALMIC | Discontinued | None | Yes | No |
SODIUM SULAMYD | SULFACETAMIDE SODIUM | 30% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS;OPHTHALMIC | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
07/21/1946 | ORIG-1 | Approval | UNKNOWN |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/17/2001 | SUPPL-18 | Labeling |
Label is not available on this site. |
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09/17/2001 | SUPPL-13 | Labeling |
Label is not available on this site. |
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10/01/1986 | SUPPL-5 | Labeling |
Label is not available on this site. |
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09/17/2001 | SUPPL-4 | Labeling |
Label is not available on this site. |
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09/17/2001 | SUPPL-3 | Labeling |
Label is not available on this site. |