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 | Suitability | 2017-07-24 | Withdrawn | Abhai, LLC |
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 | Suitability | 2017-07-24 | Withdrawn | Abhai, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.1208
per ea
Lowest NADAC/Unit
$0.1208
per ea
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 64380015701BUTALBITAL-ACETAMINOPHEN-CAFFEINE 50-325-40 MG TABLET | $0.1208 | EA | Generic | — | 2026-10-21 |
| 64380015702BUTALBITAL-ACETAMINOPHEN-CAFFEINE 50-325-40 MG TABLET | $0.1208 | EA | Generic | — | 2026-10-21 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.