Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089776
Company: CHARTWELL MOLECULAR

Products on ANDA 089776

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 089776

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
02/05/2025	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
01/30/2025	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
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.