Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070992
Company: ABRAXIS PHARM
Company: ABRAXIS PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DROPERIDOL | DROPERIDOL | 2.5MG/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 |
---|---|---|---|---|---|---|---|
11/17/1986 | 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 |
---|---|---|---|---|---|
05/27/1992 | SUPPL-10 | Labeling |
Label is not available on this site. |
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09/22/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
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09/23/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |