Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086173
Company: FOSUN PHARMA
Company: FOSUN PHARMA
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 |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
08/28/1981 | 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 |
---|---|---|---|---|---|
11/28/2000 | SUPPL-11 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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04/03/2000 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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04/06/1999 | SUPPL-9 | Labeling |
Label is not available on this site. |
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07/26/1988 | SUPPL-8 | Bioequivalence |
Label is not available on this site. |
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05/16/1983 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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05/16/1983 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |