Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084446
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 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
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.

12/11/1991 SUPPL-48 Labeling

Label is not available on this site.

05/08/1989 SUPPL-47 Labeling

Label is not available on this site.

05/04/1988 SUPPL-46 Labeling

Label is not available on this site.

11/25/1987 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

11/15/1988 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

05/06/1991 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

07/27/1982 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

07/27/1982 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

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