Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074396
Company: PIRAMAL CRITICAL
Company: PIRAMAL CRITICAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ENFLURANE | ENFLURANE | 99.9% | LIQUID;INHALATION | 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 |
---|---|---|---|---|---|---|---|
07/29/1994 | 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 |
---|---|---|---|---|---|
11/30/2000 | SUPPL-6 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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10/14/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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12/15/1997 | SUPPL-2 | Labeling |
Label is not available on this site. |
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11/14/1996 | SUPPL-1 | Labeling |
Label is not available on this site. |