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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 040821

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GLYCOPYRROLATE (GLYCOPYRROLATE)
1MG
Marketing Status: Prescription
Active Ingredient: GLYCOPYRROLATE
Proprietary Name: GLYCOPYRROLATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A040821
Product Number: 001
Approval Date: Dec 29, 2008
Applicant Holder Full Name: RISING PHARMA HOLDINGS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
GLYCOPYRROLATE (GLYCOPYRROLATE)
2MG
Marketing Status: Prescription
Active Ingredient: GLYCOPYRROLATE
Proprietary Name: GLYCOPYRROLATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A040821
Product Number: 002
Approval Date: Dec 29, 2008
Applicant Holder Full Name: RISING PHARMA HOLDINGS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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