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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 212467


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NDA 212467 describes GLYCOPYRROLATE, which is a drug marketed by Abraxis Pharm, Accord Hlthcare, Alembic, Am Regent, Amneal, Apotex, Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Lupin Ltd, Mankind Pharma, Meitheal, Omnivium Pharms, Piramal Critical, Prinston Inc, Sagent, Sandoz, Somerset Theraps Llc, Teva Parenteral, Umedica, Watson Labs, Xiromed, Zydus Pharms, Annora Pharma, Chartwell Rx, Endo Operations, Granules, Saptalis Pharms, Suven Pharms, Adaptis, Aurobindo Pharma, Dr Reddys Labs Ltd, Heritage Pharms Inc, Hikma Intl Pharms, Lgm Pharma, Natco, Oxford Pharms, Quagen, Rising, Sun Pharm Inds Ltd, and Velzen Pharma Pvt, and is included in fifty-five NDAs. It is available from fifty suppliers. Additional details are available on the GLYCOPYRROLATE profile page.

The generic ingredient in GLYCOPYRROLATE is glycopyrrolate. There are seventeen drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
Summary for 212467
Tradename:GLYCOPYRROLATE
Applicant:Suven Pharms
Ingredient:glycopyrrolate
Patents:0
Pharmacology for NDA: 212467
Medical Subject Heading (MeSH) Categories for 212467
Suppliers and Packaging for NDA: 212467
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYCOPYRROLATE glycopyrrolate SOLUTION;ORAL 212467 ANDA Taro Pharmaceuticals U.S.A. Inc. 51672-5316 51672-5316-9 1 BOTTLE in 1 CARTON (51672-5316-9) / 500 mL in 1 BOTTLE
GLYCOPYRROLATE glycopyrrolate SOLUTION;ORAL 212467 ANDA Suven Pharmaceuticals Limited 68022-0156 68022-0156-1 1 BOTTLE in 1 CARTON (68022-0156-1) / 500 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength1MG/5ML
Approval Date:Jul 5, 2022TE:AARLD:No

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