Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 017744

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MOTOFEN (ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE)
0.025MG;1MG
Marketing Status: Prescription

Active Ingredient: ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE
Proprietary Name: MOTOFEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.025MG;1MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N017744
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SEBELA IRELAND LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

MOTOFEN HALF-STRENGTH (ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE)
0.025MG;0.5MG
Marketing Status: Discontinued

Active Ingredient: ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE
Proprietary Name: MOTOFEN HALF-STRENGTH
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.025MG;0.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N017744
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SEBELA IRELAND LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information