THEOPHYLLINE | A087943 | ENDO OPERATIONS LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Searle Research and Development FDA-1986-P-0253 · 8 docket documents G.D. Searle & Co. filed this citizen petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting permission to file an Abbreviated New Drug Application for a 400-mg strength of Theo-24 anhydrous theophylline controlled-release capsules, which would differ from the list | Other | 2019-07-16 | Withdrawn | Searle Research and Development |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$5.67
per ea
Lowest NADAC/Unit
$5.67
per ea
Brand NDCs
0
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 52244020010THEO-24 ER 200 MG CAPSULE | $5.67 | EA | — | — | 2026-01-01 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.