GLYCOPYRROLATE | N014764 | AH ROBINS CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Newcastle Bioscience, LLC FDA-2023-P-4293 · 12 docket documents Newcastle Bioscience, LLC filed this citizen petition under Section 505(j)(2)(C) requesting that the FDA declare Glycopyrrolate Orally Disintegrating Tablets in strengths of 1 mg, 1.5 mg, and 2 mg suitable for submission as an ANDA, with the reference-listed drug being Robinul Forte (glycopyrrolate) | Suitability | 2023-10-03 | Granted | Newcastle Bioscience, LLC |
Attachment 4 - Approved labelling for reference‐listed drug, Robinul and Robi... FDA-2022-P-1938 · 7 docket documents 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 Lachman Consultant Services Inc. FDA-2018-P-1019 · 7 docket documents Lachman Consultant Services Inc. filed this petition on behalf of a client pursuant to Section 505(j)(2)(C) requesting that the FDA declare Glycopyrrolate Injection in strengths of 0.6 mg/3 mL and 1.0 mg/5 mL in single dose prefilled syringes suitable for submission as an abbreviated new drug applic | Other | 2018-03-08 | Withdrawn | Lachman Consultant Services Inc. |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2017-P-2869 · 7 docket documents Lachman Consultant Services, Inc. submitted this citizen petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Glycopyrrolate Orally Disintegrating Tablets in strengths of 1 mg, 1.5 mg, and 2 mg suitable for submission as an ANDA, with | Other | 2017-05-05 | Withdrawn | Lachman Consultant Services, Inc. |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2016-P-1286 · 7 docket documents Lachman Consultant Services, Inc., acting on behalf of a client, submitted a suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that Glycopyrrolate Injection, USP in a strength of 0.1 mg/0.5 mL in a prefilled syringe is | Other | 2016-05-19 | Granted | Lachman Consultant Services, Inc. |
Citizen Petition From Merz North America (Buchanan, Ingersoll and Rooney PC) FDA-2014-P-0830 · 4 docket documents Merz North America, through counsel Buchanan Ingersoll and Rooney PC, filed this citizen petition pursuant to sections 505(b)(1) and 505A of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner grant six-month pediatric exclusivity for Cuvposa (glycopyrrolate oral solution 1 | Other | 2014-07-01 | Denied | Merz North America (Buchanan, Ingersoll and Rooney PC) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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