Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 081319
Company: HIKMA

Products on ANDA 081319

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 081319

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/1992	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-20	Manufacturing (CMC)-Facility		Label is not available on this site.
05/29/2001	SUPPL-19	Manufacturing (CMC)-Facility		Label is not available on this site.
05/29/2001	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
07/31/1998	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
06/10/1996	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
06/10/1996	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
06/10/1996	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
02/08/1995	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
09/16/1994	SUPPL-11	Labeling		Label is not available on this site.
09/16/1994	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
09/16/1994	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
09/16/1994	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
02/28/1994	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
02/28/1994	SUPPL-6	Labeling		Label is not available on this site.
02/28/1994	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
02/28/1994	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
02/28/1994	SUPPL-3	Labeling		Label is not available on this site.
02/28/1994	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
11/16/1992	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 081319

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