Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085506
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
| 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 |
|---|---|---|---|---|---|---|---|
| 06/03/1977 | 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 |
|---|---|---|---|---|---|
| 12/01/1998 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/23/1994 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/21/1993 | SUPPL-63 | Labeling |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-60 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/15/1991 | SUPPL-59 | Labeling |
Label is not available on this site. |
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| 04/10/1987 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/07/1983 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |