Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089405
Company: MALLINCKRODT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TENCON ACETAMINOPHEN; BUTALBITAL 650MG;50MG 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
05/15/1990 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
11/14/1996 SUPPL-9 Labeling

Label is not available on this site.

08/30/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/29/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/15/1994 SUPPL-6 Labeling

Label is not available on this site.

02/16/1994 SUPPL-5 Labeling

Label is not available on this site.

04/16/1992 SUPPL-4 Labeling

Label is not available on this site.

05/05/1992 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/20/1991 SUPPL-2 Labeling

Label is not available on this site.

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