GLYCOPYRROLATE | N012827 | CASPER PHARMA LLC
| 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mL in single dose prefilled syringes suitable for submission as an abbreviated new drug applic | Other | 2018-03-08 | Withdrawn | Lachman Consultant Services Inc. |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Tablets in strengths of 1 mg, 1.5 mg, and 2 mg suitable for submission as an ANDA, with | Other | 2017-05-05 | Withdrawn | Lachman Consultant Services, Inc. |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 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) |
Citizen Petition from Lachman Consultant Services Inc. FDA-2006-P-0147 · 4 docket documents Lachman Consultant Services Inc. filed this citizen petition requesting that the FDA take action regarding glycopyrrolate products marketed under the proprietary names Robinul and Robinul Forte, specifically seeking clarification or regulatory action on the approved applications for these drug produ | Other | 2009-03-17 | Granted | Lachman Consultant Services Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.1462
per ea
Lowest NADAC/Unit
$0.1012
per ea
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 16571074409GLYCOPYRROLATE 2 MG TABLET | $0.1462 | EA | Generic | — | 2026-06-17 |
| 16571074309GLYCOPYRROLATE 1 MG TABLET | $0.1012 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.