Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 083247
Company: OAK PHARMS
Company: OAK PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NEMBUTAL | PENTOBARBITAL SODIUM | 30MG | SUPPOSITORY;RECTAL | Discontinued | None | No | No |
| NEMBUTAL | PENTOBARBITAL SODIUM | 60MG | SUPPOSITORY;RECTAL | Discontinued | None | No | No |
| NEMBUTAL | PENTOBARBITAL SODIUM | 120MG | SUPPOSITORY;RECTAL | Discontinued | None | No | No |
| NEMBUTAL | PENTOBARBITAL SODIUM | 200MG | SUPPOSITORY;RECTAL | 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 |
|---|---|---|---|---|---|---|---|
| 01/25/1982 | 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 |
|---|---|---|---|---|---|
| 09/24/1992 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/22/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/24/1992 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/09/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
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