Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073044
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BACLOFEN BACLOFEN 20MG 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
02/27/1992 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
06/18/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/31/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/11/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/16/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/06/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/17/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/16/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/17/1992 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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