Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077666
Company: APOTEX INC

Products on ANDA 077666

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 077666

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/22/2007	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
01/07/2021	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
11/22/2019	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/22/2019	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/22/2019	SUPPL-10	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/03/2015	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
08/29/2013	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
08/29/2013	SUPPL-6	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/28/2011	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
06/22/2009	SUPPL-3	Labeling		Label is not available on this site.
11/06/2007	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077666

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