Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 007409

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BENTYL (DICYCLOMINE HYDROCHLORIDE)
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
Active Ingredient: DICYCLOMINE HYDROCHLORIDE
Proprietary Name: BENTYL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N007409
Product Number: 003
Approval Date: Oct 15, 1984
Applicant Holder Full Name: ALLERGAN SALES LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
BENTYL (DICYCLOMINE HYDROCHLORIDE)
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
Active Ingredient: DICYCLOMINE HYDROCHLORIDE
Proprietary Name: BENTYL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N007409
Product Number: 001
Approval Date: Oct 15, 1984
Applicant Holder Full Name: ALLERGAN SALES LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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