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. filed an amendment to its suitability petition FDA-2024-P-5783, originally submitted December 13, 2024, seeking permission to file an ANDA for Dicyclomine Hydrochloride Capsules USP in 20 mg and 40 mg strengths. The amendment provides the reference listed drug product la

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 document provided is prescribing information for dicyclomine hydrochloride tablets and does not contain details identifying who filed a citizen petition, what specific action was requested, or the petition's regulatory mechanism. The material consists of FDA-approved labeling highlights and full

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-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 PC filed this suitability petition regarding BENTYL (dicyclomine hydrochloride), an antispasmodic anticholinergic agent indicated for functional bowel and irritable bowel syndrome available in capsule, tablet, and intramuscular injection formulations. The petition requests F

FDA-2019-P-5970

IQVIA RDS Inc. filed this petition on behalf of a client requesting that the FDA designate an alternative reference standard for Dicyclomine Hydrochloride Capsules under section 505(j) of the FD&C Act, since the current reference listed drug BENTYL (dicyclomine hydrochloride) capsules manufactured b

FDA-2019-P-4101

IQVIA RDS Inc. filed this citizen petition on behalf of a client requesting that the FDA designate an alternative reference standard for dicyclomine hydrochloride tablets under section 505(j) to enable development of an ANDA, since the current reference listed drug BENTYL tablets by Allergan Sales L

FDA-2019-P-3800

Hyman, Phelps & McNamara P.C. filed this citizen petition requesting that the FDA designate ANDA 084285 (Dicyclomine Hydrochloride Capsules, 10 mg held by Lannett Co Inc) or another appropriate ANDA as a new reference standard for the drug product, as the current reference standard approved under ND

FDA-2018-P-1892

Aurobindo Pharma USA, Inc. filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 10.25(a), 10.30, and 314.93 to request that the FDA designate an alternative reference standard for conducting in vivo bioequivalence studies to support an ANDA applicat

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