Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 005213

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HYCODAN (HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE)
1.5MG/5ML;5MG/5ML
Marketing Status: Prescription
Active Ingredient: HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
Proprietary Name: HYCODAN
Dosage Form; Route of Administration: SYRUP; ORAL
Strength: 1.5MG/5ML;5MG/5ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AA
Application Number: N005213
Product Number: 002
Approval Date: Jul 26, 1988
Applicant Holder Full Name: GENUS LIFESCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
HYCODAN (HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE)
1.5MG;5MG
Marketing Status: Prescription
Active Ingredient: HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
Proprietary Name: HYCODAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1.5MG;5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AA
Application Number: N005213
Product Number: 001
Approval Date: Jul 26, 1988
Applicant Holder Full Name: GENUS LIFESCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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