Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084445
Company: ROBINS AH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENAPHEN W/ CODEINE NO. 3 ACETAMINOPHEN; CODEINE PHOSPHATE 325MG;30MG 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-61 Manufacturing (CMC)

Label is not available on this site.

12/11/1991 SUPPL-59 Labeling

Label is not available on this site.

01/21/1994 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

05/08/1989 SUPPL-57 Labeling

Label is not available on this site.

05/04/1988 SUPPL-56 Labeling

Label is not available on this site.

11/25/1987 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

11/25/1987 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

11/25/1987 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

11/25/1987 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

11/15/1988 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

02/05/1991 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

09/18/1985 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

09/18/1985 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

09/18/1985 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

09/18/1985 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

07/27/1982 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

07/28/1982 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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