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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 088383


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NDA 088383 describes SOMOPHYLLIN-CRT, which is a drug marketed by Graham Dm and is included in five NDAs. Additional details are available on the SOMOPHYLLIN-CRT profile page.

The generic ingredient in SOMOPHYLLIN-CRT is theophylline. There are thirty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the theophylline profile page.
Summary for 088383
Tradename:SOMOPHYLLIN-CRT
Applicant:Graham Dm
Ingredient:theophylline
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength300MG
Approval Date:Feb 27, 1985TE:RLD:No

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