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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080936
Company: GENUS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISONIAZID ISONIAZID 100MG 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
08/24/1972 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
02/05/2025 SUPPL-61 Labeling-Package Insert

Label is not available on this site.
10/24/2024 SUPPL-56 Labeling-Package Insert

Label is not available on this site.
10/24/2024 SUPPL-55 Labeling-Package Insert

Label is not available on this site.
12/21/1999 SUPPL-49 Manufacturing (CMC)-Facility

Label is not available on this site.
03/16/2000 SUPPL-48 Labeling

Label is not available on this site.
03/16/2000 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.
03/16/2000 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.
03/16/2000 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.
03/16/2000 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.
05/20/1999 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.
12/01/1998 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.
06/15/1998 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.
04/07/1997 SUPPL-40 Labeling

Label is not available on this site.
09/18/1997 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.
12/23/1994 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.
10/11/1994 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.
04/03/1992 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.
04/03/1992 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.
01/25/1990 SUPPL-32 Labeling

Label is not available on this site.
07/11/1989 SUPPL-31 Labeling

Label is not available on this site.
04/06/1987 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.
02/21/1986 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.
02/21/1986 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.
02/21/1986 SUPPL-25 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.
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