DICYCLOMINE HYDROCHLORIDE | A084285 | LANNETT CO INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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. |
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. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.0761
per ea
Lowest NADAC/Unit
$0.0761
per ea
Brand NDCs
0
Generic NDCs
5
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00527058601DICYCLOMINE 10 MG CAPSULE | $0.0761 | EA | Generic | — | 2026-06-17 |
| 00527058610DICYCLOMINE 10 MG CAPSULE | $0.0761 | EA | Generic | — | 2026-06-17 |
| 60687036901DICYCLOMINE 10 MG CAPSULE | $0.0761 | EA | Generic | — | 2026-06-17 |
| 62135071890DICYCLOMINE 10 MG CAPSULE | $0.0761 | EA | Generic | — | 2026-06-17 |
| 00904698761DICYCLOMINE 10 MG CAPSULE | $0.0761 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.