ACETAMINOPHEN; BUTALBITAL; CAFFEINE | A040261 | HIKMA PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 2 Butalbital, Acetaminophen and Caffeine- butalbital, acetaminophe... FDA-2017-P-4388 Abhai, LLC filed a suitability petition regarding butalbital, acetaminophen, and caffeine tablets manufactured by Par Pharmaceutical, requesting FDA determination of suitability for abbreviated new drug application (ANDA) filing or related regulatory pathway consideration for this combination produc | Suitability | 2017-07-24 | Open | Abhai |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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