ACETAMINOPHEN; BUTALBITAL; CAFFEINE | A040885 | LGM PHARMA SOLUTIONS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Abhai, LLC FDA-2017-P-4388 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 | Open | Abhai |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.