THEOPHYLLINE | A090430 | ALEMBIC PHARMACEUTICALS LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Nostrum Pharmaceuticals, LLC. FDA-2018-P-2104 · 5 docket documents Nostrum Pharmaceuticals, LLC filed this citizen petition requesting that the FDA amend the Orange Book to designate Alembic Pharmaceutical Ltd.'s Theophylline Extended Release Tablets, 300 mg (ANDA 090430) as an alternate reference standard to facilitate a site transfer of Nostrum's approved Theochr | 505(q) | 2018-06-01 | Withdrawn | Nostrum Pharmaceuticals, LLC. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.9799
per ea
Lowest NADAC/Unit
$0.3324
per ea
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 62332002631THEOPHYLLINE ER 450 MG TABLET | $0.9799 | EA | Generic | — | 2026-06-17 |
| 62332002531THEOPHYLLINE ER 300 MG TABLET | $0.3324 | 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.