CLORAZEPATE DIPOTASSIUM | A071858 | AUROBINDO PHARMA LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Granules Pharmaceuticals Inc FDA-2017-P-5799 · 5 docket documents Granules Pharmaceuticals Inc. submitted this Section 505(j) citizen petition requesting that FDA designate Mylan Pharmaceuticals' ANDA 071858 for Clorazepate Dipotassium Tablets 15 mg as an alternative reference standard for developing an ANDA, because the current reference standard TRANXENE Cloraze | Other | 2017-09-19 | GrantedUnverified summary | Granules Pharmaceuticals Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.9004
per ea
Lowest NADAC/Unit
$0.5815
per ea
Brand NDCs
0
Generic NDCs
10
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 13107028401CLORAZEPATE 15 MG TABLET | $0.9004 | EA | Generic | — | 2026-08-19 |
| 13107032101CLORAZEPATE 15 MG TABLET | $0.9004 | EA | Generic | — | 2026-08-19 |
| 13107032001CLORAZEPATE 7.5 MG TABLET | $0.8727 | EA | Generic | — | 2026-08-19 |
| 13107032005CLORAZEPATE 7.5 MG TABLET | $0.8727 | EA | Generic | — | 2026-08-19 |
| 13107028301CLORAZEPATE 7.5 MG TABLET | $0.8727 | EA | Generic | — | 2026-08-19 |
| 13107028305CLORAZEPATE 7.5 MG TABLET | $0.8727 | EA | Generic | — | 2026-08-19 |
Showing 6 of 10 NDCs.
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.