Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 005378

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DESOXYN (METHAMPHETAMINE HYDROCHLORIDE)
5MG
Marketing Status: Prescription
Active Ingredient: METHAMPHETAMINE HYDROCHLORIDE
Proprietary Name: DESOXYN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AA
Application Number: N005378
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: RECORDATI RARE DISEASES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
DESOXYN (METHAMPHETAMINE HYDROCHLORIDE)
5MG
Marketing Status: Discontinued
Active Ingredient: METHAMPHETAMINE HYDROCHLORIDE
Proprietary Name: DESOXYN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N005378
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: RECORDATI RARE DISEASES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
DESOXYN (METHAMPHETAMINE HYDROCHLORIDE)
10MG
Marketing Status: Discontinued
Active Ingredient: METHAMPHETAMINE HYDROCHLORIDE
Proprietary Name: DESOXYN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N005378
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: RECORDATI RARE DISEASES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
DESOXYN (METHAMPHETAMINE HYDROCHLORIDE)
15MG
Marketing Status: Discontinued
Active Ingredient: METHAMPHETAMINE HYDROCHLORIDE
Proprietary Name: DESOXYN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 15MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N005378
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: RECORDATI RARE DISEASES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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