Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200266
Company: APOTEX

Products on ANDA 200266

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200266

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/10/2013	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/14/2022	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/15/2019	SUPPL-7	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/15/2019	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/15/2019	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/15/2019	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
11/15/2019	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
11/15/2019	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
03/19/2015	SUPPL-1	Labeling-Package Insert		Label is not available on this site.