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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-seven drug master file entries for this compound. Ninety suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.

Summary for NDA: 062475

Tradename:
DOXY 100
Applicant:
Fresenius Kabi Usa
Ingredient:
doxycycline hyclate
Patents:0
Therapeutic Class:Antibacterials
Dental and Oral Agents
Formulation / Manufacturing:see details

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) > 100 mg 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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/VIAL
Approval Date:Dec 9, 1983TE:APRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 200MG BASE/VIAL
Approval Date:Dec 9, 1983TE:RLD:Yes


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