Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008662
Company: SANDOZ

Products on NDA 008662

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NYDRAZID	ISONIAZID	100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 008662

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/1952	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/19/2002	SUPPL-18	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
02/05/2002	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
05/25/2001	SUPPL-16	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/08/1997	SUPPL-15	Labeling		Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. Label is not available on this site.
12/31/1992	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
07/23/1985	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
11/10/1986	SUPPL-11	Labeling		Label is not available on this site.
06/14/1988	SUPPL-10	Labeling		Label is not available on this site.
04/17/1979	SUPPL-9	Labeling		Label is not available on this site.
05/15/1978	SUPPL-8	Labeling		Label is not available on this site.
05/28/1976	SUPPL-6	Labeling		Label is not available on this site.