OMEPRAZOLE | A075347 | ACTAVIS LABORATORIES FL INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 1 GastroGard® Oral Paste, labeling by Merial, rev 05-2014 re Suita... FDA-2017-P-1225 Aurora Pharmaceutical LLC filed a suitability petition requesting that the FDA determine whether GastroGard Oral Paste, a gastric ulcer treatment for horses, is suitable for generic development and approval as an abbreviated new drug application (ANDA). The petition references the product's labeling | Suitability | 2017-02-28 | Open | Aurora Pharmaceutical LLC 2 |
Suitability Petition from Aurora Pharmaceutical LLC 2 FDA-2017-P-1225 Aurora Pharmaceutical LLC submitted this petition under Section 512(n)(3) of the Federal Food, Drug and Cosmetic Act in February 2017 requesting FDA permission to file an abbreviated new animal drug application for Omeprazole Suspension 4.5% w/v, a generic version of the reference listed drug Gastro | Suitability | 2017-02-28 | Open | Aurora Pharmaceutical LLC 2 |
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.
No patent or exclusivity listings for this strength.