Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080614
Company: DR REDDYS
Company: DR REDDYS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 02/11/1986 | 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 |
|---|---|---|---|---|---|
| 02/19/1999 | SUPPL-43 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 02/02/1999 | SUPPL-42 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 03/25/1998 | SUPPL-39 | Labeling |
Label is not available on this site. |
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| 08/28/1996 | SUPPL-37 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 07/23/1991 | SUPPL-36 | Labeling |
Label is not available on this site. |
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| 11/14/1990 | SUPPL-35 | Labeling |
Label is not available on this site. |
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| 11/15/1988 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/14/1988 | SUPPL-32 | Labeling |
Label is not available on this site. |
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| 06/16/1986 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/11/1985 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/22/1984 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |