Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072123
Company: AM REGENT
Company: AM REGENT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DROPERIDOL | DROPERIDOL | 2.5MG/ML | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/24/1988 | 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 |
---|---|---|---|---|---|
02/21/2023 | SUPPL-22 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
01/10/2002 | SUPPL-12 | Labeling |
Label is not available on this site. |
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03/25/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/02/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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02/17/1995 | SUPPL-5 | Labeling |
Label is not available on this site. |
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02/28/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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10/11/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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05/26/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
DROPERIDOL
INJECTABLE;INJECTION; 2.5MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DROPERIDOL | DROPERIDOL | 2.5MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 072123 | AM REGENT |
DROPERIDOL | DROPERIDOL | 2.5MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 208197 | HIKMA |