Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077777
Company: SANDOZ INC

Products on ANDA 077777

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
ALPRAZOLAM	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077777

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/2006	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
06/30/2023	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/30/2023	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/22/2011	SUPPL-4	Labeling-Package Insert		Label is not available on this site.