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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080157
Company: NOVITIUM PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PYRAZINAMIDE PYRAZINAMIDE 500MG TABLET;ORAL Prescription AB Yes 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
06/03/1971 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
02/28/2001 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/2001 SUPPL-17 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

02/28/2001 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/03/1999 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/23/1994 SUPPL-14 Labeling

Label is not available on this site.

05/16/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/20/1992 SUPPL-11 Labeling

Label is not available on this site.

10/22/1991 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/04/1990 SUPPL-9 Labeling

Label is not available on this site.

10/19/1987 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/10/1982 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

PYRAZINAMIDE

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PYRAZINAMIDE PYRAZINAMIDE 500MG TABLET;ORAL Prescription No AB 081319 AKORN
PYRAZINAMIDE PYRAZINAMIDE 500MG TABLET;ORAL Prescription No AB 212541 MACLEODS PHARMS LTD
PYRAZINAMIDE PYRAZINAMIDE 500MG TABLET;ORAL Prescription Yes AB 080157 NOVITIUM PHARMA
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