Drugs@FDA: FDA-Approved Drugs
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. |