Viewing data from:

DICYCLOMINE HYDROCHLORIDE

ANDA

DICYCLOMINE HYDROCHLORIDE | A085223 | WATSON LABORATORIES INC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-7006 The law firm Hyman, Phelps & McNamara, P.C. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Dicyclomine Hydrochloride Tablets, 10 mg, suitable for submission as an ANDA, with the reference listed drug being Allerga	Suitability	2025-12-12	Open	Hyman

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

API Supply Chain4 active DMFs2 inactive

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

OLON SPADICYCLOMINE HYDROCHLORIDE

DMF 23031974

INDOCO REMEDIES LTDDICYCLOMINE HYDROCHLORIDE USP

DMF 222952008

HONOUR LAB LTDDICYCLOMINE HYDROCHLORIDE

DMF 369772022

AMI LIFESCIENCES PRIVATE LTDDICYCLOMINE HYDROCHLORIDE

DMF 400782024

NORISTAN LTDInactiveDICYCLOMINE HYDROCHLORIDE

DMF 94581991

PCASInactiveDICYCLOMINE HYDROCHLORIDE

DMF 104601993

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

Products (1)

#001 — 20MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 30, 1986

No patent or exclusivity listings for this strength.