GLYCOPYRROLATE | A090963 | HIKMA FARMACEUTICA (PORTUGAL) SA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Fresenius Kabi USA, LLC FDA-2016-P-1952 · 5 docket documents Fresenius Kabi USA, LLC submitted this petition requesting that the FDA determine whether Robinul, Glycopyrrolate Injection (NDA 017558), held by Eurohealth International, was voluntarily withdrawn from sale for reasons of safety or efficacy, as required under 21 CFR 314.161 before ANDAs referring t | 505(q) | 2016-07-08 | Granted | Fresenius Kabi USA, LLC |
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. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$1.33
per ml
Lowest NADAC/Unit
$1.33
per ml
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00143968225GLYCOPYRROLATE 0.2 MG/ML VIAL | $1.33 | ML | Generic | — | 2026-06-17 |
| 72572022525GLYCOPYRROLATE 0.2 MG/ML VIAL | $1.33 | ML | 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.