Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076122
Company: MYLAN

• Other Important Information from FDA

Products on ANDA 076122

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET;ORAL	Prescription	AB	No	No
MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET;ORAL	Prescription	AB	No	No
MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076122

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/19/2003	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76122tapd.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076122.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/15/2022	SUPPL-29	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/04/2020	SUPPL-27	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/04/2020	SUPPL-26	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/22/2019	SUPPL-25	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/22/2019	SUPPL-24	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/22/2019	SUPPL-22	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/27/2015	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
03/18/2014	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
06/28/2011	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
11/06/2007	SUPPL-10	Labeling		Label is not available on this site.
11/06/2007	SUPPL-9	Labeling		Label is not available on this site.
09/26/2005	SUPPL-2	Labeling		Label is not available on this site.
12/29/2004	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076122

MIRTAZAPINE

TABLET;ORAL; 15MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET;ORAL	Prescription	No	AB	076219	AIPING PHARM INC
MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET;ORAL	Prescription	No	AB	077666	APOTEX INC
MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET;ORAL	Prescription	No	AB	076921	AUROBINDO
MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET;ORAL	Prescription	No	AB	076122	MYLAN
MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET;ORAL	Prescription	No	AB	216751	PRASCO
MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET;ORAL	Prescription	No	AB	076541	SUN PHARM INDS INC
MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET;ORAL	Prescription	No	AB	076119	TEVA
REMERON	MIRTAZAPINE	15MG	TABLET;ORAL	Prescription	Yes	AB	020415	ORGANON

TABLET;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET;ORAL	Prescription	No	AB	076219	AIPING PHARM INC
MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET;ORAL	Prescription	No	AB	077666	APOTEX INC
MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET;ORAL	Prescription	No	AB	076921	AUROBINDO
MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET;ORAL	Prescription	No	AB	076122	MYLAN
MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET;ORAL	Prescription	No	AB	216751	PRASCO
MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET;ORAL	Prescription	No	AB	076541	SUN PHARM INDS INC
MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET;ORAL	Prescription	No	AB	076119	TEVA
REMERON	MIRTAZAPINE	30MG	TABLET;ORAL	Prescription	Yes	AB	020415	ORGANON

TABLET;ORAL; 45MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET;ORAL	Prescription	No	AB	076219	AIPING PHARM INC
MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET;ORAL	Prescription	No	AB	077666	APOTEX INC
MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET;ORAL	Prescription	No	AB	076921	AUROBINDO
MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET;ORAL	Prescription	No	AB	076122	MYLAN
MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET;ORAL	Prescription	No	AB	216751	PRASCO
MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET;ORAL	Prescription	No	AB	076541	SUN PHARM INDS INC
MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET;ORAL	Prescription	No	AB	076119	TEVA