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Generated: October 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207201

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NDA 207201 describes GLYCOPYRROLATE, which is a drug marketed by Abraxis Pharm, Amneal Pharms Co, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Luitpold, Somerset Theraps Llc, Teva Parenteral, Watson Labs, Anda Repository, Appco Pharma Llc, Aurolife Pharma Llc, Dr Reddys Labs Ltd, Hikma Intl Pharms, Leading Pharma Llc, Natco Pharma Ltd, Nexgen Pharma, Oxford Pharms, Par Pharm, Renata, Santos Biotech, and Sun Pharm Inds Ltd, and is included in twenty-seven NDAs. It is available from thirty-two 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 suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
Summary for 207201
Tradename:GLYCOPYRROLATE
Applicant:Appco Pharma Llc
Ingredient:glycopyrrolate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207201
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 207201
Suppliers and Packaging for NDA: 207201
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 207201 ANDA Heritage Pharmaceuticals Inc. 23155-606 23155-606-01 100 TABLET in 1 BOTTLE (23155-606-01)
GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 207201 ANDA Heritage Pharmaceuticals Inc. 23155-607 23155-607-01 100 TABLET in 1 BOTTLE (23155-607-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jan 3, 2017TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Jan 3, 2017TE:AARLD:No

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