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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080157
Company: NOVITIUM PHARMA

Products on ANDA 080157

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PYRAZINAMIDE	PYRAZINAMIDE	500MG	TABLET;ORAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080157

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
04/20/1992	SUPPL-36	Labeling		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 080157

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	HIKMA
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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