Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084446
Company: ROBINS AH
Company: ROBINS AH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHENAPHEN W/ CODEINE NO. 4 | ACETAMINOPHEN; CODEINE PHOSPHATE | 325MG;60MG | CAPSULE;ORAL | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 07/22/1975 | 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 |
|---|---|---|---|---|---|
| 04/07/1998 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/11/1991 | SUPPL-48 | Labeling |
Label is not available on this site. |
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| 05/08/1989 | SUPPL-47 | Labeling |
Label is not available on this site. |
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| 05/04/1988 | SUPPL-46 | Labeling |
Label is not available on this site. |
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| 11/25/1987 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/15/1988 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/06/1991 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/27/1982 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/27/1982 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |