BENTYL

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

FDA-2024-P-5783

Rising Pharma Holdings, Inc. submitted this suitability petition under section 502(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 CFR section 314.93 requesting FDA approval to file an Abbreviated New Drug Application for Dicyclomine Hydrochloride Capsules USP in 20 mg and 40 mg strength

FDA-2021-P-0074

The provided document is an Orange Book entry for Bentyl (dicyclomine hydrochloride) tablets showing NDA 007409 approved on October 15, 1984, with marketing status listed as discontinued. The document does not contain information about a citizen petition filed by Hyman, Phelps & McNamara PC or any s

FDA-2021-P-0074

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, 40 mg (scored), suitable for submission as an ANDA, based on Allergan Sales LLC's BENTYL Tablets, 20

FDA-2018-P-1869

Aurobindo Pharma USA Inc. filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate the approved generic product Dicyclomine Hydrochloride Capsules USP, 10 mg (ANDA #085082) of Watson Laboratories Inc. as an alternative reference s