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Last Updated: March 2, 2021

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Details for New Drug Application (NDA): 086178

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NDA 086178 describes GLYCOPYRROLATE, which is a drug marketed by Abraxis Pharm, Accord Hlthcare, Am Regent, Amneal, Apotex, Aurobindo Pharma Ltd, Caplin, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Piramal Critical, Prinston Inc, Riconpharma Llc, Sandoz Inc, Somerset Theraps Llc, Teva Parenteral, Watson Labs, Alembic Labs, Aurolife Pharma Llc, Dr Reddys Labs Ltd, Heritage Pharms Inc, Hikma Intl Pharms, Kenton, Leading Pharma Llc, Lgm Pharma, Natco Pharma Ltd, Oxford Pharms, Par Pharm, Renata, Rising, and Sun Pharm Inds Ltd, and is included in thirty-eight NDAs. It is available from thirty-seven 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. Forty-three suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
Summary for 086178
Tradename:GLYCOPYRROLATE
Applicant:Watson Labs
Ingredient:glycopyrrolate
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 086178

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength2MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Medtronic
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Express Scripts
McKesson
Moodys

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