GLYCOPYRROLATE | N017558 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 2 - Draft Insert Label for Glycopyrrolate Orally Disintegrating Ta... FDA-2023-P-4293 Newcastle Bioscience, LLC filed a suitability petition regarding glycopyrrolate orally disintegrating tablets, requesting FDA approval for the labeling of this formulation. The petition seeks confirmation that the proposed product formulation and labeling are suitable for submission as an abbreviate | Suitability | 2023-10-03 | Open | Newcastle Bioscience |
Attachment 3 - Approved labeling for reference-listed drug, Robinul Forte (gl... FDA-2023-P-4293 Newcastle Bioscience, LLC filed a citizen petition requesting approval of an ANDA for a generic glycopyrrolate tablet product, referencing the approved labeling for Robinul Forte (glycopyrrolate) Tablets as the reference-listed drug under the suitability petition mechanism. | Suitability | 2023-10-03 | Open | Newcastle Bioscience |
Attachment 4 - Approved labelling for reference‐listed drug, Robinul and Robi... FDA-2022-P-1938 Suven Pharmaceuticals Limited filed a suitability petition regarding glycopyrrolate tablets (Robinul and Robinul Forte) as reference-listed drugs under the ANDA pathway. The petition requests FDA confirmation of the appropriateness of these reference-listed drugs for use in abbreviated new drug appl | Suitability | 2022-08-18 | Open | Suven Pharmaceuticals Limited |
CITIZEN PETITION FROM EXELA PHARMA SCIENCES, LLC. FDA-2018-P-4769 Exela Pharma Sciences, LLC submitted this citizen petition pursuant to Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA assign a therapeutic equivalence code of "AP" in the Orange Book for GLYRX-PF (glycopyrrolate injection) in strengths of 0.2 mg/mL and 0.4 mg/2 | Other | 2018-12-17 | Withdrawn | EXELA PHARMA SCIENCES |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.