Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085266
Company: MD PHARM
Company: MD PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DI-ATRO | 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 |
|---|---|---|---|---|---|---|---|
| 04/18/1977 | 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 |
|---|---|---|---|---|---|
| 03/30/1992 | SUPPL-71 | Labeling |
Label is not available on this site. |
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| 04/05/1989 | SUPPL-70 | Labeling |
Label is not available on this site. |
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| 10/18/1988 | SUPPL-69 | Labeling |
Label is not available on this site. |
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| 05/25/1988 | SUPPL-68 | Labeling |
Label is not available on this site. |