Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070039
Company: STRIDES PHARMA

Products on ANDA 070039

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070039

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/29/1985	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
10/15/2024	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
07/08/2024	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
01/05/2024	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
03/31/2022	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
08/19/2021	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
07/29/2019	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
04/16/1992	SUPPL-11	Labeling		Label is not available on this site.
11/01/1988	SUPPL-8	Bioequivalence		Label is not available on this site.
06/16/1988	SUPPL-6	Labeling		Label is not available on this site.
05/23/1986	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/23/1986	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.