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Serving 500+ biopharmaceutical companies globally:

Healthtrust
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Generated: June 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017558

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NDA 017558 describes ROBINUL, which is a drug marketed by Casper Pharma Llc, West-ward Pharms Int, and Robins Ah, and is included in three NDAs. It is available from four suppliers. Additional details are available on the ROBINUL profile page.

The generic ingredient in ROBINUL is glycopyrrolate. There are fifteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

Summary for NDA: 017558

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 017558

Mechanism of ActionCholinergic Antagonists

Suppliers and Packaging for NDA: 017558

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROBINUL
glycopyrrolate
INJECTABLE;INJECTION 017558 NDA West-ward Pharmaceutical Corp. 0641-6033 0641-6033-25 25 VIAL in 1 CARTON (0641-6033-25) > 1 mL in 1 VIAL (0641-6033-01)
ROBINUL
glycopyrrolate
INJECTABLE;INJECTION 017558 NDA West-ward Pharmaceutical Corp. 0641-6034 0641-6034-25 25 VIAL in 1 CARTON (0641-6034-25) > 2 mL in 1 VIAL (0641-6034-01)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes


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Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
Federal Trade Commission
Teva
Merck
Queensland Health
Cipla
Cantor Fitzgerald
US Department of Justice
Chubb
Colorcon

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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