Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076307
Company: ACTAVIS LABS FL INC

• Other Important Information from FDA

Products on ANDA 076307

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	No	No
MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	No	No
MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076307

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/17/2003	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
02/25/2020	SUPPL-22	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
02/25/2020	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/07/2007	SUPPL-14	Labeling		Label is not available on this site.
11/07/2007	SUPPL-11	Labeling		Label is not available on this site.
07/14/2005	SUPPL-8	Labeling		Label is not available on this site.
02/28/2006	SUPPL-7	Manufacturing (CMC)-New Strength		Label is not available on this site.
02/28/2006	SUPPL-6	Labeling		Label is not available on this site.
02/28/2006	SUPPL-5	Manufacturing (CMC)-New Strength		Label is not available on this site.
11/23/2004	SUPPL-4	Labeling		Label is not available on this site.
02/28/2006	SUPPL-2	Labeling		Label is not available on this site.
02/28/2006	SUPPL-1	Manufacturing (CMC)-New Strength		Label is not available on this site.