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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216751
Company: PRASCO

Products on ANDA 216751

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MIRTAZAPINE	MIRTAZAPINE	7.5MG	TABLET;ORAL	Prescription	AB	No	No
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 216751

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/18/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/28/2023	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 216751

MIRTAZAPINE

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	076921	AUROBINDO
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

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

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