Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083245
Company: EPIC PHARMA LLC
Company: EPIC PHARMA LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NEMBUTAL SODIUM | PENTOBARBITAL SODIUM | 100MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
02/13/1975 | 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 |
---|---|---|---|---|---|
02/06/2019 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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04/20/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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05/22/1992 | SUPPL-9 | Labeling |
Label is not available on this site. |