OMEPRAZOLE | N019810 | ASTRAZENECA PHARMACEUTICALS LP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Lupin Pharmaceuticals, Inc. - ANDA Suitability Citizen Petition-[FDA-2008-P-0... FDA-2008-P-0080 Lupin Pharmaceuticals, Inc. filed this suitability petition pursuant to 21 CFR 314.93 and Section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting FDA approval to submit an abbreviated new drug application for Esomeprazole Delayed-Release Tablets in 20 mg and 40 mg strengths, which | Suitability | 2008-02-07 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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