BENZTROPINE MESYLATE | A204713 | NUVO PHARMACEUTICAL INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-7927 Hyman, Phelps & McNamara, P.C. filed a suitability petition requesting that the FDA evaluate whether a particular drug product or manufacturing process is suitable for regulatory approval. The petition asks the FDA to provide guidance or a determination regarding regulatory pathways such as NDA or A | Suitability | 2026-07-20 | Open | Hyman, Phelps & McNamara, P.C. |
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2018-P-2720 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
$0.0900
per ea
Lowest NADAC/Unit
$0.0638
per ea
Brand NDCs
0
Generic NDCs
6
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 11534016909BENZTROPINE MES 2 MG TABLET | $0.0900 | EA | Generic | — | 2026-10-21 |
| 11534016910BENZTROPINE MES 2 MG TABLET | $0.0900 | EA | Generic | — | 2026-10-21 |
| 11534016809BENZTROPINE MES 1 MG TABLET | $0.0739 | EA | Generic | — | 2026-10-21 |
| 11534016810BENZTROPINE MES 1 MG TABLET | $0.0739 | EA | Generic | — | 2026-10-21 |
| 11534016709BENZTROPINE MES 0.5 MG TAB | $0.0638 | EA | Generic | — | 2026-10-21 |
| 11534016710BENZTROPINE MES 0.5 MG TAB | $0.0638 | EA | Generic | — | 2026-10-21 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.