ROPINIROLE HYDROCHLORIDE | A201576 | DR REDDYS LABORATORIES LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from CellTrion, Inc. FDA-2020-P-1016 · 10 docket documents Celltrion, Inc. filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate Dr. Reddy's Laboratories Ltd's Ropinirole Hydrochloride Extended Release Tablets 2 mg (ANDA 201576) as an alternative reference standard for bioequivalence t | Other | 2020-03-03 | Withdrawn | CellTrion, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$2.23
per ea
Lowest NADAC/Unit
$0.4256
per ea
Brand NDCs
0
Generic NDCs
9
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 55111072830ROPINIROLE HCL ER 12 MG TABLET | $2.23 | EA | Generic | — | 2026-06-17 |
| 55111072730ROPINIROLE HCL ER 6 MG TABLET | $1.35 | EA | Generic | — | 2026-06-17 |
| 55111072790ROPINIROLE HCL ER 6 MG TABLET | $1.35 | EA | Generic | — | 2026-06-17 |
| 55111066230ROPINIROLE HCL ER 8 MG TABLET | $1.12 | EA | Generic | — | 2026-06-17 |
| 55111066290ROPINIROLE HCL ER 8 MG TABLET | $1.12 | EA | Generic | — | 2026-06-17 |
| 55111066190ROPINIROLE HCL ER 4 MG TABLET | $0.5707 | EA | Generic | — | 2026-06-17 |
Showing 6 of 9 NDCs.
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.