Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085035
Company: R AND S PHARMA
Company: R AND S 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 |
|---|---|---|---|---|---|---|---|
| 07/05/1977 | ORIG-1 | Approval |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/085239_diphenoxylate_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/04/1988 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 07/26/1988 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/26/1988 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/17/1983 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/17/1983 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/17/1983 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/28/1982 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/15/1988 | SUPPL-1 | Bioequivalence |
Label is not available on this site. |