ASPIRIN; HYDROCODONE BITARTRATE | A089420 | SCHWARZ PHARMA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Xspire Pharma, LLC - Citizen Petition FDA-2012-P-1267 · 3 docket documents 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mg) with a different strength than the reference listed drug ANDA A089-420 for Azdone (Aspiri | Other | 2012-12-31 | Withdrawn | — |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 · 5 docket documents 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(hydrocodone bitartrate and aspirin) Tablets, 5 mg/500 mg, held by Schwarz Pharma under ANDA 89-420, was voluntarily withdrawn or withheld from sale for reasons of safety or e | 505(q) | 2010-06-28 | Granted | — |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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