Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040090
Company: ANDA REPOSITORY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISONIAZID ISONIAZID 100MG TABLET;ORAL Prescription AA No No
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
06/26/1997 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
08/13/2002 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

07/31/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

ISONIAZID

TABLET;ORAL; 100MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ISONIAZID ISONIAZID 100MG TABLET;ORAL Prescription No AA 040090 ANDA REPOSITORY
ISONIAZID ISONIAZID 100MG TABLET;ORAL Prescription No AA 080936 BARR
ISONIAZID ISONIAZID 100MG TABLET;ORAL Prescription No AA 202610 THEPHARMANETWORK LLC

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 040090 ANDA REPOSITORY
ISONIAZID ISONIAZID 300MG TABLET;ORAL Prescription No AA 080937 BARR
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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