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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210997

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GLYRX-PF (GLYCOPYRROLATE)
0.2MG/ML (0.2MG/ML)
Marketing Status: Prescription
Active Ingredient: GLYCOPYRROLATE
Proprietary Name: GLYRX-PF
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR, INTRAVENOUS
Strength: 0.2MG/ML (0.2MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210997
Product Number: 001
Approval Date: Jul 11, 2018
Applicant Holder Full Name: EXELA PHARMA SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
GLYRX-PF (GLYCOPYRROLATE)
0.4MG/2ML (0.2MG/ML)
Marketing Status: Prescription
Active Ingredient: GLYCOPYRROLATE
Proprietary Name: GLYRX-PF
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR, INTRAVENOUS
Strength: 0.4MG/2ML (0.2MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210997
Product Number: 002
Approval Date: Jul 11, 2018
Applicant Holder Full Name: EXELA PHARMA SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
GLYRX-PF (GLYCOPYRROLATE)
0.6MG/3ML (0.2MG/ML)
Marketing Status: Prescription
Active Ingredient: GLYCOPYRROLATE
Proprietary Name: GLYRX-PF
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR, INTRAVENOUS
Strength: 0.6MG/3ML (0.2MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210997
Product Number: 004
Approval Date: Dec 14, 2020
Applicant Holder Full Name: EXELA PHARMA SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
GLYRX-PF (GLYCOPYRROLATE)
1MG/5ML (0.2MG/ML)
Marketing Status: Prescription
Active Ingredient: GLYCOPYRROLATE
Proprietary Name: GLYRX-PF
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR, INTRAVENOUS
Strength: 1MG/5ML (0.2MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210997
Product Number: 003
Approval Date: Apr 9, 2020
Applicant Holder Full Name: EXELA PHARMA SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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