DICYCLOMINE HYDROCHLORIDE | A040319 | AUROBINDO PHARMA USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 59651071901DICYCLOMINE 10 MG CAPSULE | $0.0761 | EA | Generic | — | 2026-06-17 |
| 59651071999DICYCLOMINE 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.