Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084600
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 20MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/20/1975 | 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-47 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/09/1998 | SUPPL-46 | Labeling |
Label is not available on this site. |
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| 12/23/1994 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/11/1994 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/11/1991 | SUPPL-40 | Labeling |
Label is not available on this site. |
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| 05/01/1991 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/24/1990 | SUPPL-37 | Labeling |
Label is not available on this site. |
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| 06/01/1989 | SUPPL-36 | Labeling |
Label is not available on this site. |
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| 03/20/1987 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/25/1985 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/25/1985 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |