ACETAMINOPHEN; BUTALBITAL; CAFFEINE | A040885 | LGM PHARMA SOLUTIONS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Abhai, LLC FDA-2017-P-4388 · 5 docket documents Abhai, LLC filed this suitability petition under 21 CFR 314.93 requesting FDA approval to submit an ANDA for Acetaminophen, Butalbital, and Caffeine Tablets at a new strength of 300 mg/50 mg/40 mg, which differs from the previously approved 325 mg/50 mg/40 mg strength referenced in ANDA 040511. | Suitability | 2017-07-24 | Withdrawn | Abhai, LLC |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2011-P-0167 · 3 docket documents Lachman Consultant Services, Inc., on behalf of a client, filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Butalbital and Acetaminophen Capsules 50 mg/300 mg suitable for submission as an abbreviated new drug applicati | Other | 2011-03-25 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$8.82
per ea
Lowest NADAC/Unit
$0.3355
per ea
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 52544008001FIORICET 50-300-40 MG CAPSULE | $8.82 | EA | — | $0.3355 | 2026-01-01 |
| 00591264001BUTALBITAL-ACETAMINOPHEN-CAFFEINE 50-300-40 MG CAPSULE | $0.3355 | EA | Generic | — | 2026-06-17 |
| 00591264005BUTALBITAL-ACETAMINOPHEN-CAFFEINE 50-300-40 MG CAPSULE | $0.3355 | 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.