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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087425
Company: HIKMA INTL PHARMS

Products on ANDA 087425

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISONIAZID	ISONIAZID	300MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087425

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/14/1981	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
02/05/2025	SUPPL-38	Labeling-Package Insert		Label is not available on this site.
01/31/2025	SUPPL-36	Labeling-Package Insert		Label is not available on this site.
01/31/2025	SUPPL-34	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
10/21/2008	SUPPL-31	Labeling		Label is not available on this site.
10/01/1998	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
08/12/1997	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
08/12/1997	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
09/08/1997	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
09/08/1997	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
02/18/1997	SUPPL-21	Labeling		Label is not available on this site.
08/12/1997	SUPPL-20	Labeling		Label is not available on this site.
08/12/1997	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
10/23/1995	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
10/23/1995	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
10/23/1995	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
10/23/1995	SUPPL-15	Labeling		Label is not available on this site.
10/23/1995	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
10/23/1995	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
10/23/1995	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.

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