Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 083978
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE 650MG;65MG TABLET;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
10/25/1974 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
02/25/1998 SUPPL-212 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-211 Manufacturing (CMC)

Label is not available on this site.

08/10/2000 SUPPL-210 Manufacturing (CMC)

Label is not available on this site.

03/07/1997 SUPPL-209 Manufacturing (CMC)

Label is not available on this site.

01/13/1994 SUPPL-208 Manufacturing (CMC)

Label is not available on this site.

10/31/1991 SUPPL-206 Manufacturing (CMC)

Label is not available on this site.

10/31/1991 SUPPL-205 Labeling

Label is not available on this site.

10/31/1991 SUPPL-204 Manufacturing (CMC)

Label is not available on this site.

01/31/1990 SUPPL-203 Manufacturing (CMC)

Label is not available on this site.

09/25/1986 SUPPL-200 Manufacturing (CMC)

Label is not available on this site.

06/28/1984 SUPPL-199 Manufacturing (CMC)

Label is not available on this site.

04/25/1983 SUPPL-198 Manufacturing (CMC)

Label is not available on this site.

06/08/1982 SUPPL-152 Manufacturing (CMC)

Label is not available on this site.

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