DICYCLOMINE HYDROCHLORIDE | A085082 | WATSON LABORATORIES 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. |
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.
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 |
|---|---|---|---|---|---|
| 00591079401DICYCLOMINE 10 MG CAPSULE | $0.0761 | EA | Generic | — | 2026-06-17 |
| 00591079410DICYCLOMINE 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.