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CLOZAPINE

ANDA

CLOZAPINE | A201824 | MYLAN PHARMACEUTICALS INC

4 strengths0 unique patents0 unique exclusivities

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 5 NDCs

Highest NADAC/Unit

$21.23

per ea

Lowest NADAC/Unit

$1.69

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00378381701CLOZAPINE ODT 200 MG TABLET	$21.23	EA	Generic	—	2026-08-19
00378381601CLOZAPINE ODT 150 MG TABLET	$14.97	EA	Generic	—	2026-08-19
00378381501CLOZAPINE ODT 100 MG TABLET	$4.25	EA	Generic	—	2026-08-19
51079028804CLOZAPINE ODT 100 MG TABLET	$4.25	EA	Generic	—	2026-08-19
00378381301CLOZAPINE ODT 25 MG TABLET	$1.69	EA	Generic	—	2026-08-19

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain12 active DMFs4 inactive

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

MEDICHEM SACLOZAPINE

DMF 105341993

SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTDCLOZAPINE

DMF 111951994

CAMBREX PROFARMACO MILANO SRLCLOZAPINE

DMF 116921995

WUHAN SHIJI PHARMACEUTICAL CO LTDCLOZAPINE

DMF 198222006

SHOUGUANG FUKANG PHARMACEUTICAL CO LTDCLOZAPINE

DMF 251822011

MATRIX PHARMACORP PRIVATE LTDCLOZAPINE USP

DMF 273792013

COHANCE LIFESCIENCES LTDCLOZAPINE USP

DMF 319992017

AURORE LIFE SCIENCES PRIVATE LTDCLOZAPINE USP

DMF 366452021

GLOBAL CALCIUM PRIVATE LTDCLOZAPINE USP

DMF 368692022

MANKIND PHARMA LTDCLOZAPINE USP

DMF 375402023

R L FINE CHEM PVT LTDCLOZAPINE

DMF 380712023

SMS PHARMACEUTICALS LTDCLOZAPINE USP

DMF 399132024

AREVIPHARMA GMBHInactiveCLOZAPINE

DMF 108621994

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENTInactiveCLOZAPINE

DMF 110981994

SELOC FRANCEInactiveCLOZAPINE

DMF 124011997

HUIZHOU DONGJIANG PHARMACEUTICAL FACTORY GUANGDONGInactiveCLOZAPINE, USP

DMF 128731998

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 17, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#002 — 25MG

0 patents0 exclusivities▴

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Sep 15, 2015

No patent or exclusivity listings for this strength.

#003 — 100MG

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Sep 15, 2015

#004 — 150MG

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Aug 7, 2023

#005 — 200MG

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Aug 7, 2023