Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088584
Company: PHARM RES ASSOC
Company: PHARM RES ASSOC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DHC PLUS | ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE | 356.4MG;30MG;16MG | 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 |
---|---|---|---|---|---|---|---|
03/04/1986 | 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 |
---|---|---|---|---|---|
05/04/1998 | SUPPL-16 | Labeling |
Label is not available on this site. |
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06/09/1994 | SUPPL-10 | Labeling |
Label is not available on this site. |
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02/24/1994 | SUPPL-8 | Labeling |
Label is not available on this site. |
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05/12/1993 | SUPPL-7 | Labeling |
Label is not available on this site. |
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04/16/1993 | SUPPL-6 | Labeling |
Label is not available on this site. |
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06/07/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |