Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 19, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 086480

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NDA 086480 describes THEOPHYL-SR, which is a drug marketed by Ortho Mcneil Pharm and is included in two NDAs. Additional details are available on the THEOPHYL-SR profile page.

The generic ingredient in THEOPHYL-SR is theophylline. There are thirty-six drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the theophylline profile page.
Summary for 086480
Tradename:THEOPHYL-SR
Applicant:Ortho Mcneil Pharm
Ingredient:theophylline
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength125MG
Approval Date:Feb 8, 1985TE:RLD:No

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