Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 18, 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 Acp Nimble, Alembic Pharms Ltd, Impax Labs Inc, Lupin Ltd, Mayne Pharma Inc, Mylan Pharms Inc, Par Pharm, Sandoz Inc, Sun Pharm Inds Ltd, Watson Labs, Zydus Pharms, 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, Changzhou Pharm, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Pvt Form, Ranbaxy, Superpharm, Warner Chilcott, Actavis Elizabeth, Prinston Inc, Amneal Pharms Co, Apotex Inc, Cadila, Caribe Holdings, Emcure Pharms Ltd, Epic Pharma Llc, Heritage Pharma, Larken Labs, Novel Labs Inc, and Vintage Pharms, and is included in eighty-five NDAs. It is available from forty 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. Seventy-six suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 207757
Tradename:DOXYCYCLINE
Applicant:Zydus Pharms
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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