Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088898
Company: CENT PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN AND HYDROCODONE BITARTRATE ACETAMINOPHEN; HYDROCODONE BITARTRATE 500MG;5MG 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
03/27/1985 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
11/29/1999 SUPPL-18 Manufacturing (CMC)-Facility

Label is not available on this site.

09/12/1996 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/20/1994 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/24/1994 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/24/1994 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/24/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/24/1994 SUPPL-12 Labeling

Label is not available on this site.

01/24/1994 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/29/1989 SUPPL-9 Labeling

Label is not available on this site.

01/08/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/19/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/21/1989 SUPPL-5 Labeling

Label is not available on this site.

10/19/1992 SUPPL-4 Labeling

Label is not available on this site.

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