An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076119
Company: TEVA

Other Important Information from FDA

Products on ANDA 076119

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 076119

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/24/2003	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76119tapd.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076119.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/24/2020	SUPPL-30	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
02/24/2020	SUPPL-27	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/24/2020	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
10/24/2014	SUPPL-24	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/31/2013	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
01/31/2013	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
07/19/2010	SUPPL-20	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/06/2007	SUPPL-14	Labeling		Label is not available on this site.
11/06/2007	SUPPL-13	Labeling		Label is not available on this site.
07/21/2006	SUPPL-12	Labeling		Label is not available on this site.
07/12/2005	SUPPL-6	Labeling		Label is not available on this site.
12/29/2004	SUPPL-4	Labeling		Label is not available on this site.
06/19/2003	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076119

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

Top