Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086950
Company: LEDERLE
Company: LEDERLE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE | 0.025MG;2.5MG | TABLET;ORAL | Discontinued | None | No | No |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
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06/16/1983 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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06/16/1983 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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09/09/1982 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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06/16/1983 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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09/09/1982 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |