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Generated: January 23, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207757

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NDA 207757 describes DOXYCYCLINE, which is a drug marketed by Alembic Pharms Ltd, G And W Labs Inc, Impax Labs Inc, Lupin Ltd, Mayne Pharma Inc, Mylan Pharms Inc, Par Pharm, Sandoz Inc, Sun Pharm Inds Ltd, Watson Labs, Zydus Pharms Usa Inc, Chartwell Life Sci, Mylan Labs Ltd, West-ward Pharms Int, Heritage Pharms Inc, Lannett Co Inc, Mylan, Sun Pharm Industries, Pliva, Medicis, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Amneal Pharms, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Pvt Form, Ranbaxy, Superpharm, Warner Chilcott, Actavis Elizabeth, Prinston Inc, Amneal Pharms Co, Caribe Holdings, Emcure Pharms Ltd, Epic Pharma Llc, Ivax Sub Teva Pharms, Larken Labs, Novel Labs Inc, and Vintage Pharms, and is included in eighty-one NDAs. It is available from forty-two suppliers. Additional details are available on the DOXYCYCLINE profile page.

The generic ingredient in DOXYCYCLINE is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Ninety-five suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 207757
Tradename:DOXYCYCLINE
Applicant:Zydus Pharms Usa Inc
Ingredient:doxycycline hyclate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207757
Suppliers and Packaging for NDA: 207757
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXYCYCLINE doxycycline hyclate INJECTABLE;INJECTION 207757 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-910 68382-910-10 10 VIAL in 1 CARTON (68382-910-10) > 10 mL in 1 VIAL
DOXYCYCLINE doxycycline hyclate INJECTABLE;INJECTION 207757 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-911 68382-911-01 1 VIAL in 1 CARTON (68382-911-01) > 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/VIAL
Approval Date:Sep 28, 2017TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 200MG BASE/VIAL
Approval Date:Sep 28, 2017TE:APRLD:No

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