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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 087400


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NDA 087400 describes THEOCHRON, which is a drug marketed by Nostrum Pharms Llc and is included in one NDA. It is available from one supplier. Additional details are available on the THEOCHRON profile page.

The generic ingredient in THEOCHRON is theophylline. There are thirty-six drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the theophylline profile page.
Summary for 087400
Tradename:THEOCHRON
Applicant:Nostrum Pharms Llc
Ingredient:theophylline
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 087400
Suppliers and Packaging for NDA: 087400
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THEOCHRON theophylline TABLET, EXTENDED RELEASE;ORAL 087400 ANDA Nostrum Laboratories, Inc. 29033-057 29033-057-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (29033-057-01)
THEOCHRON theophylline TABLET, EXTENDED RELEASE;ORAL 087400 ANDA Nostrum Laboratories, Inc. 29033-058 29033-058-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (29033-058-01)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength300MG
Approval Date:Jan 11, 1983TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Feb 21, 1985TE:RLD:No

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength200MG
Approval Date:Feb 21, 1985TE:RLD:No

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