Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088831
Company: VALEANT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHRENILIN FORTE 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
06/19/1985 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
05/08/2002 SUPPL-29 Manufacturing (CMC)-Facility

Label is not available on this site.

02/19/2002 SUPPL-28 Manufacturing (CMC)-Facility

Label is not available on this site.

12/06/2001 SUPPL-27 Manufacturing (CMC)-Facility

Label is not available on this site.

08/16/2001 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

09/27/2000 SUPPL-25 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

05/09/2000 SUPPL-24 Manufacturing (CMC)-Facility

Label is not available on this site.

09/27/2000 SUPPL-23 Labeling

Label is not available on this site.

09/27/2000 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

09/27/2000 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

04/17/1996 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/28/1997 SUPPL-19 Labeling

Label is not available on this site.

04/28/1997 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

01/21/1997 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/29/1994 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/10/1994 SUPPL-15 Labeling

Label is not available on this site.

12/07/1993 SUPPL-14 Labeling

Label is not available on this site.

05/08/1992 SUPPL-13 Labeling

Label is not available on this site.

07/01/1992 SUPPL-11 Labeling

Label is not available on this site.

03/28/1991 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/28/1991 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/02/1992 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/28/1991 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/12/1989 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/12/1989 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/17/1988 SUPPL-4 Labeling

Label is not available on this site.

04/12/1989 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/12/1989 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/28/1991 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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