Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089776
Company: LANNETT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LANIAZID 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
06/13/1988 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
11/21/2001 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/21/2001 SUPPL-18 Labeling

Label is not available on this site.

11/21/2001 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/21/2001 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

07/23/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/14/1997 SUPPL-14 Labeling

Label is not available on this site.

12/11/1996 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/11/1996 SUPPL-12 Labeling

Label is not available on this site.

12/11/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/11/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/11/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/11/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/09/1990 SUPPL-1 Labeling

Label is not available on this site.

LANIAZID

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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