Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070231
Company: INWOOD LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARBAMAZEPINE CARBAMAZEPINE 200MG 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
08/14/1986 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
10/05/2000 SUPPL-11 Labeling

Label is not available on this site.

12/30/1998 SUPPL-10 Labeling

Label is not available on this site.

11/23/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/08/1997 SUPPL-8 Labeling

Label is not available on this site.

02/22/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/10/1990 SUPPL-6 Labeling

Label is not available on this site.

03/07/1990 SUPPL-5 Labeling

Label is not available on this site.

10/05/1989 SUPPL-3 Labeling

Label is not available on this site.

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