Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076541
Company: SUN PHARM INDS INC

• Other Important Information from FDA

Products on ANDA 076541

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
MIRTAZAPINE	MIRTAZAPINE	7.5MG	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076541

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/22/2004	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
09/15/2022	SUPPL-27	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/25/2020	SUPPL-26	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/25/2020	SUPPL-25	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/20/2019	SUPPL-24	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/17/2016	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
10/17/2016	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
06/17/2015	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
06/03/2008	SUPPL-11	Labeling		Label is not available on this site.
11/07/2007	SUPPL-10	Labeling		Label is not available on this site.
10/29/2007	SUPPL-9	Labeling		Label is not available on this site.
03/26/2007	SUPPL-8	Labeling		Label is not available on this site.
07/12/2005	SUPPL-5	Labeling		Label is not available on this site.
07/12/2005	SUPPL-4	Labeling		Label is not available on this site.
03/10/2005	SUPPL-3	Labeling		Label is not available on this site.
03/10/2005	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076541

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	219721	ANNORA PHARMA
MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET;ORAL	Prescription	No	AB	077666	APOTEX
MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET;ORAL	Prescription	No	AB	076921	AUROBINDO
MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET;ORAL	Prescription	No	AB	076219	CHARTWELL RX
MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET;ORAL	Prescription	No	AB	220104	MICRO LABS
MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET;ORAL	Prescription	No	AB	076122	MYLAN
MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET;ORAL	Prescription	No	AB	219919	NOVITIUM PHARMA
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	219721	ANNORA PHARMA
MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET;ORAL	Prescription	No	AB	077666	APOTEX
MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET;ORAL	Prescription	No	AB	076921	AUROBINDO
MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET;ORAL	Prescription	No	AB	076219	CHARTWELL RX
MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET;ORAL	Prescription	No	AB	220104	MICRO LABS
MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET;ORAL	Prescription	No	AB	076122	MYLAN
MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET;ORAL	Prescription	No	AB	219919	NOVITIUM PHARMA
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	219721	ANNORA PHARMA
MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET;ORAL	Prescription	No	AB	077666	APOTEX
MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET;ORAL	Prescription	No	AB	076921	AUROBINDO
MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET;ORAL	Prescription	No	AB	076219	CHARTWELL RX
MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET;ORAL	Prescription	No	AB	220104	MICRO LABS
MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET;ORAL	Prescription	No	AB	076122	MYLAN
MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET;ORAL	Prescription	No	AB	219919	NOVITIUM PHARMA
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

TABLET;ORAL; 7.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MIRTAZAPINE	MIRTAZAPINE	7.5MG	TABLET;ORAL	Prescription	No	AB	219721	ANNORA PHARMA
MIRTAZAPINE	MIRTAZAPINE	7.5MG	TABLET;ORAL	Prescription	No	AB	076921	AUROBINDO
MIRTAZAPINE	MIRTAZAPINE	7.5MG	TABLET;ORAL	Prescription	No	AB	220104	MICRO LABS
MIRTAZAPINE	MIRTAZAPINE	7.5MG	TABLET;ORAL	Prescription	No	AB	219919	NOVITIUM PHARMA
MIRTAZAPINE	MIRTAZAPINE	7.5MG	TABLET;ORAL	Prescription	No	AB	216751	PRASCO
MIRTAZAPINE	MIRTAZAPINE	7.5MG	TABLET;ORAL	Prescription	No	AB	076541	SUN PHARM INDS INC