GUANFACINE HYDROCHLORIDE | A074796 | AUROBINDO PHARMA USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hyman, Phelps & McNamara P.C FDA-2019-P-3803 · 4 docket documents Hyman, Phelps & McNamara P.C. filed this citizen petition requesting that the FDA designate ANDA 075109 for Guanfacine Hydrochloride Tablets (equivalent to 1mg and 2mg base) as a reference standard for bioequivalence testing in lieu of the commercially unavailable ANDA 074796, and amend the Orange B | 505(q) | 2019-08-13 | Withdrawn | Hyman, Phelps & McNamara P.C |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.2590
per ea
Lowest NADAC/Unit
$0.1470
per ea
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 59651084101GUANFACINE 2 MG TABLET | $0.2590 | EA | Generic | — | 2026-06-17 |
| 59651084001GUANFACINE 1 MG TABLET | $0.1470 | 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.