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MIRTAZAPINE

ANDA

MIRTAZAPINE | A076122 | MYLAN PHARMACEUTICALS INC

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: REMERON(TE code: AB)

API Supply Chain18 active DMFs4 inactive

14 active API suppliers hold Drug Master Files for this ingredient.

ASPEN OSS BVMIRTAZAPINE

DMF 104571993

TAPI NL BVMIRTAZAPINE

DMF 153232001

MEDICHEM SAMIRTAZAPINE

DMF 157492001

NEULAND LABORATORIES LTDMIRTAZAPINE

DMF 160072002

SUN PHARMACEUTICAL INDUSTRIES LTDMIRTAZAPINE USP [HEMIHYDRATE]

DMF 161132002

APITORIA PHARMA PRIVATE LTDMIRTAZAPINE ANHYDROUS USP

DMF 164902003

MATRIX PHARMACORP PRIVATE LTDMIRTAZAPINE USP (ANHYDROUS)

DMF 193692006

MEGAFINE PHARMA P LTDMIRTAZAPINE ANHYDROUS USP (NON-STERILE DRUG SUBSTANCE)

DMF 205702007

MEGAFINE PHARMA P LTDMIRTAZAPINE HEMIHYDRATE USP (NON STERILE DRUG SUBSTANCE)

DMF 230032009

SYN-TECH CHEM AND PHARM CO LTDMIRTAZAPINE USP

DMF 297482015

NEULAND LABORATORIES LTDMIRTAZAPINE USP (ACETONE ROUTE)

DMF 308502016

MAITHRI DRUGS PRIVATE LTDMIRTAZAPINE USP [ROUTE CODE - MZ)

DMF 313222017

MAITHRI DRUGS PRIVATE LTDMIRTAZAPINE ANHYDROUS USP

DMF 370132022

HETERO DRUGS LTDMIRTAZAPINE

DMF 383412023

MICRO LABS LTDMIRTAZAPINE USP

DMF 387992023

MAHI DRUGS PRIVATE LTDMIRTAZAPINE USP

DMF 402032024

APITORIA PHARMA PRIVATE LTDMIRTAZAPINE USP (PROCESS-II)

DMF 413292025

ZHEJIANG LIAOYUAN PHARMACEUTICAL CO LTDMIRTAZAPINE

DMF 421602025

DIOSYNTH BVInactiveMIRTAZAPINE

DMF 83571989

SUMITOMO CHEMICAL CO LTDInactiveMIRTAZAPINE

DMF 153002001

ANGELINI ACRAF SPAInactiveMIRTAZAPINE

DMF 160142002

MYLAN LABORATORIES LTDInactiveMIRTAZAPINE USP (HEMIHYDRATE)

DMF 175212004

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 10, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

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#001 — 15MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 19, 2003

No patent or exclusivity listings for this strength.

#002 — 30MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 19, 2003

#003 — 45MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 19, 2003