Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 012827

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ROBINUL (GLYCOPYRROLATE)
1MG Marketing Status: Prescription

Active Ingredient: GLYCOPYRROLATE
Proprietary Name: ROBINUL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AA
Application Number: N012827
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: CASPER PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ROBINUL FORTE (GLYCOPYRROLATE)
2MG Marketing Status: Prescription

Active Ingredient: GLYCOPYRROLATE
Proprietary Name: ROBINUL FORTE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AA
Application Number: N012827
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: CASPER PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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