ASPIRIN; HYDROCODONE BITARTRATE | A089420 | SCHWARZ PHARMA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Xspire Pharma, LLC - Citizen Petition FDA-2012-P-1267 Xspire Pharma, LLC filed an ANDA Suitability Petition under 21 CFR 314.93 requesting permission to submit an abbreviated new drug application for Aspradone (Aspirin, Hydrocodone Bitartrate Tablets, 325 mg/5 mg) with a different strength than the reference listed drug ANDA A089-420 for Azdone (Aspiri | Other | 2012-12-31 | Withdrawn | — |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2010-P-0338 Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA determine whether Azdone (hydrocodone bitartrate and aspirin) Tablets, 5 mg/500 mg, held by Schwarz Pharma under ANDA 89-420, was voluntarily withdrawn or withheld from sale for reasons of safety or e | 505(q) | 2010-06-28 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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