DICYCLOMINE HYDROCHLORIDE | N007409 | ALLERGAN SALES LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-7006 · 9 docket documents 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 | Granted | Hyman, Phelps & McNamara, P.C. |
Suitability Petition from Rising Pharma Holdings, Inc. FDA-2024-P-5783 · 9 docket documents 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 | Suitability | 2024-12-17 | Granted | Rising Pharma Holdings, Inc. |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2021-P-0074 · 6 docket documents 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 | Suitability | 2021-01-26 | Granted | Hyman, Phelps & McNamara, P.C. |
Citizen Petition from IQVIA RDS Inc FDA-2019-P-5970 · 5 docket documents 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 | 505(q) | 2019-12-18 | Denied | IQVIA RDS Inc |
Citizen Petition from IQVIA RDS Inc. FDA-2019-P-4101 · 3 docket documents 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 | 505(q) | 2019-09-03 | Granted | IQVIA RDS Inc. |
Citizen Petition from Hyman, Phelps & McNamara P.C. FDA-2019-P-3800 · 3 docket documents 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 | 505(q) | 2019-08-13 | Granted | Hyman, Phelps & McNamara P.C. |
Citizen Petiton from Aurobindo Pharma USA, Inc FDA-2018-P-1892 · 4 docket documents 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 | Other | 2018-05-16 | Granted | — |
Citizen Petition from Aurobindo Pharma USA Inc FDA-2018-P-1869 · 9 docket documents 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 | 505(q) | 2018-05-14 | Granted | Aurobindo Pharma USA Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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