ACETAMINOPHEN; BUTALBITAL; CAFFEINE | A040511 | STRIDES PHARMA INTERNATIONAL AG
| 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 |
Attachment 1 Orange Book; Approved Drug Products with Therapeutic Equivalence... FDA-2017-P-4388 Abhai, LLC filed a suitability petition regarding ANDA 040511 requesting FDA evaluation of whether a proposed generic drug product meets regulatory standards for approval as a therapeutic equivalent to an approved innovator drug. | Suitability | 2017-07-24 | Open | Abhai |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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