BENZTROPINE MESYLATE | A040103 | AIPING PHARMACEUTICAL INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2018-P-2720 · 4 docket documents Hyman, Phelps & McNamara, P.C. filed this citizen petition requesting that the FDA amend the Orange Book to designate ANDA 204713 (or another appropriate ANDA) as an additional Reference Standard for Benztropine Mesylate Tablets in 0.5 mg, 1 mg, and 2 mg strengths, because the current reference stan | 505(q) | 2018-07-13 | Open | Hyman, Phelps & McNamara, P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.0924
per ea
Lowest NADAC/Unit
$0.0633
per ea
Brand NDCs
0
Generic NDCs
6
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 50228022701BENZTROPINE MES 2 MG TABLET | $0.0924 | EA | Generic | — | 2026-06-17 |
| 50228022710BENZTROPINE MES 2 MG TABLET | $0.0924 | EA | Generic | — | 2026-06-17 |
| 50228022601BENZTROPINE MES 1 MG TABLET | $0.0746 | EA | Generic | — | 2026-06-17 |
| 50228022610BENZTROPINE MES 1 MG TABLET | $0.0746 | EA | Generic | — | 2026-06-17 |
| 50228022501BENZTROPINE MES 0.5 MG TAB | $0.0633 | EA | Generic | — | 2026-06-17 |
| 50228022510BENZTROPINE MES 0.5 MG TAB | $0.0633 | 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.