Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083244
Company: SCIEGEN PHARMS INC
Company: SCIEGEN PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NEMBUTAL | PENTOBARBITAL | 18.2MG/5ML | ELIXIR;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 |
---|---|---|---|---|---|---|---|
01/08/1975 | 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 |
---|---|---|---|---|---|
09/20/1995 | SUPPL-10 | Labeling |
Label is not available on this site. |
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01/31/1989 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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03/30/1984 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |