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Generated: November 21, 2018

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Details for New Drug Application (NDA): 062475

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NDA 062475 describes DOXY 200, which is a drug marketed by Fresenius Kabi Usa and is included in one NDA. It is available from two suppliers. Additional details are available on the DOXY 200 profile page.

The generic ingredient in DOXY 200 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 062475
Tradename:DOXY 200
Applicant:Fresenius Kabi Usa
Ingredient:doxycycline hyclate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 062475
Ingredient-typeTetracyclines
Suppliers and Packaging for NDA: 062475
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXY 100 doxycycline hyclate INJECTABLE;INJECTION 062475 ANDA General Injectables & Vaccines, Inc 52584-028 52584-028-11 1 VIAL in 1 BAG (52584-028-11) > 10 mL in 1 VIAL
DOXY 100 doxycycline hyclate INJECTABLE;INJECTION 062475 ANDA Fresenius Kabi USA, LLC 63323-130 63323-130-13 10 VIAL in 1 TRAY (63323-130-13) > 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/VIAL
Approval Date:Dec 9, 1983TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 200MG BASE/VIAL
Approval Date:Dec 9, 1983TE:APRLD:No

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