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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091406

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NDA 091406 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, Mylan, Sun Pharm Industries, Pliva, Medicis, Actavis Labs Fl Inc, 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, Epic Pharma Llc, Ivax Sub Teva Pharms, Larken Labs, Novel Labs Inc, and Vintage Pharms, and is included in seventy-eight NDAs. It is available from thirty-eight suppliers. Additional details are available on the DOXYCYCLINE profile page.

The generic ingredient in DOXYCYCLINE is doxycycline hyclate. There are twenty-seven drug master file entries for this compound. Ninety-four suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.

Summary for 091406

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antibacterials
Dental and Oral Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 091406

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXYCYCLINE doxycycline hyclate INJECTABLE;INJECTION 091406 ANDA Pfizer Laboratories Div Pfizer Inc 0069-0104 0069-0104-04 10 VIAL in 1 CARTON (0069-0104-04) > 10 mL in 1 VIAL (0069-0104-01)
DOXYCYCLINE doxycycline hyclate INJECTABLE;INJECTION 091406 ANDA Mylan Institutional LLC 67457-437 67457-437-10 10 VIAL in 1 CARTON (67457-437-10) > 10 mL in 1 VIAL (67457-437-00)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/VIAL
Approval Date:Aug 21, 2012TE:APRLD:No


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