AMANTADINE HYDROCHLORIDE | A076186 | UPSHER SMITH LABORATORIES LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Axinn, Veltrop & Harkrider LLP FDA-2017-P-6028 · 9 docket documents Axinn, Veltrop & Harkrider LLP filed this petition pursuant to Section 505(j)(2)(C) requesting that the FDA declare Amantadine Hydrochloride Tablets, 200 mg, suitable for submission in an ANDA, with bioequivalence to be demonstrated against the 100 mg reference standard by comparing one 200 mg table | Other | 2017-10-04 | Granted | Axinn, Veltrop & Harkrider LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.3154
per ea
Lowest NADAC/Unit
$0.3154
per ea
Brand NDCs
0
Generic NDCs
3
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00832011100AMANTADINE 100 MG TABLET | $0.3154 | EA | Generic | — | 2026-06-17 |
| 00832011103AMANTADINE 100 MG TABLET | $0.3154 | EA | Generic | — | 2026-06-17 |
| 00832011150AMANTADINE 100 MG TABLET | $0.3154 | 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.