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Generated: November 13, 2018

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Details for New Drug Application (NDA): 050751

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NDA 050751 describes ATRIDOX, which is a drug marketed by Tolmar and is included in one NDA. It is available from one supplier. Additional details are available on the ATRIDOX profile page.

The generic ingredient in ATRIDOX is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Ninety-seven suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 050751
Tradename:ATRIDOX
Applicant:Tolmar
Ingredient:doxycycline hyclate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 050751
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATRIDOX doxycycline hyclate SYSTEM, EXTENDED RELEASE;PERIODONTAL 050751 NDA Den-Mat Holdings, LLC 59883-100 59883-100-02 2 TRAY in 1 CARTON (59883-100-02) > 1 KIT in 1 TRAY (59883-100-01) * 1 POWDER in 1 SYRINGE (59883-101-01) * 450 mg in 1 SYRINGE (59883-102-01)
ATRIDOX doxycycline hyclate SYSTEM, EXTENDED RELEASE;PERIODONTAL 050751 NDA Den-Mat Holdings, LLC 59883-100 59883-100-06 6 TRAY in 1 CARTON (59883-100-06) > 1 KIT in 1 TRAY (59883-100-01) * 1 POWDER in 1 SYRINGE (59883-101-01) * 450 mg in 1 SYRINGE (59883-102-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYSTEM, EXTENDED RELEASE;PERIODONTALStrength50MG
Approval Date:Sep 3, 1998TE:RLD:Yes

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