ACETAMINOPHEN; ASPIRIN; CAFFEINE | N020802 | HALEON US HOLDINGS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Medtech Products Inc FDA-2018-P-0674 · 6 docket documents Medtech Products Inc. filed this petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act to request permission to submit an ANDA for acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg in a powder dosage form for over-the-counter migraine treatment, referencing the RLD E | Other | 2018-02-13 | Granted | Medtech Products Inc |
Citizen Petition from Medtech Products Inc. FDA-2016-P-1212 · 6 docket documents Medtech Products Inc. filed a petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting permission to submit an ANDA for acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg in a powder-for-solution dosage form for over-the-counter treatment of migraine, with the | Other | 2016-05-02 | Withdrawn | Medtech Products Inc. |
Citizen Petition from Medtech Products Inc. FDA-2016-P-1213 · 6 docket documents Medtech Products Inc. filed this Section 505(j)(2)(C) petition on April 25, 2016, requesting FDA approval to submit an ANDA for acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg in a powder dosage form for over-the-counter migraine treatment, using Excedrin Migraine tablets as the reference l | Other | 2016-05-02 | Withdrawn | Medtech Products Inc. |
Citizen Petition from Medtech Products Inc. FDA-2016-P-1211 · 6 docket documents Medtech Products Inc. filed this petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act on April 25, 2016, requesting permission to submit an ANDA for acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg in a chewable tablet dosage form for over-the-counter treatment of | Other | 2016-05-02 | Withdrawn | Medtech Products Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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