Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080937
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISONIAZID ISONIAZID 300MG TABLET;ORAL Prescription AA 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
08/24/1972 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
12/21/1999 SUPPL-56 Manufacturing (CMC)-Facility

Label is not available on this site.

03/09/2000 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

03/09/2000 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

03/09/2000 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

03/09/2000 SUPPL-52 Labeling

Label is not available on this site.

03/09/2000 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

05/20/1999 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

08/10/1998 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

06/15/1998 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

04/07/1997 SUPPL-46 Labeling

Label is not available on this site.

09/18/1997 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

01/25/1990 SUPPL-38 Labeling

Label is not available on this site.

07/11/1989 SUPPL-37 Labeling

Label is not available on this site.

04/06/1987 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

02/21/1986 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

12/13/1985 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

02/21/1986 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

02/21/1986 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

12/13/1985 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

09/07/1983 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/26/1983 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

ISONIAZID

TABLET;ORAL; 300MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ISONIAZID ISONIAZID 300MG TABLET;ORAL Prescription No AA 080937 BARR
ISONIAZID ISONIAZID 300MG TABLET;ORAL Prescription No AA 040090 MIKART
ISONIAZID ISONIAZID 300MG TABLET;ORAL Prescription Yes AA 008678 SANDOZ
ISONIAZID ISONIAZID 300MG TABLET;ORAL Prescription No AA 202610 THEPHARMANETWORK LLC
LANIAZID ISONIAZID 300MG TABLET;ORAL Prescription No AA 089776 LANNETT

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