Viewing data from:

CLOTRIMAZOLE

ANDA

CLOTRIMAZOLE | A076387 | HIKMA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Custo Pharm Inc - Citizen Petition FDA-2013-P-0028 · 4 docket documents Custo Pharm Inc filed this citizen petition requesting that the FDA designate Roxane's Clotrimazole Troche/Lozenge under ANDA 076387 as a second reference listed drug in the Orange Book, to enable filing of additional ANDAs for generic clotrimazole troche products, since the current RLD Mycelex (Bay	Other	2013-01-03	Withdrawn	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$0.2872

per ea

Lowest NADAC/Unit

$0.2872

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00054414622CLOTRIMAZOLE 10 MG TROCHE	$0.2872	EA	Generic	—	2026-06-17
00054414623CLOTRIMAZOLE 10 MG TROCHE	$0.2872	EA	Generic	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$11.89

Highest Price

$25.27

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00054-4146-22CLOTRIMAZOLE 10MG TROCHE	$11.89	FSS	Golden State Medical Supply, Inc.	06/14/2028
00054-4146-23CLOTRIMAZOLE 10MG TROCHE	$25.27	FSS	Golden State Medical Supply, Inc.	06/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain5 active DMFs7 inactive

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

ERREGIERRE SPACLOTRIMAZOLE USP-EP

DMF 63241986

FIS FABBRICA ITALIANA SINTETICI SPACLOTRIMAZOLE

DMF 75481988

OLON SPACLOTRIMAZOLE

DMF 98061992

AMOLI ORGANICS PVT LTDCLOTRIMAZOLE USP

DMF 264832012

SNJ LABS PVT LTDCLOTRIMAZOLE USP

DMF 359022021

SIFAVITOR SPAInactiveCLOTRIMAZOLE USP XX

DMF 54891984

MILES PHARMACEUTICAL DIV MILES INCInactiveCLOTRIMAZOLE 250 MG ORAL TABLETS

DMF 55571984

CUTTER BIOLOGICAL DIV MILES LABORATORIES INCInactiveCLOTRIMAZOLE

DMF 67291986

BAYER AGInactiveCLOTRIMAZOLE

DMF 67711987

CORDEN PHARMA BERGAMO SPAInactiveCLOTRIMAZOLE

DMF 107131994

SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTDInactiveCLOTRIMAZOLE

DMF 197162006

JIANGSU YUNYANG GROUP PHARMACEUTICAL CO LTDInactiveCLOTRIMAZOLE

DMF 203972007

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 30, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG

0 patents0 exclusivities▴

TROCHE/LOZENGE;ORAL | Approved: Jul 29, 2004

No patent or exclusivity listings for this strength.