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Generated: October 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065356

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NDA 065356 describes DOXYCYCLINE, which is a drug marketed by Heritage Pharms Inc, Mylan Labs Ltd, Zydus Pharms Usa Inc, Mylan, Sandoz Inc, Lupin Ltd, Watson Labs, G And W Labs Inc, West-ward Pharms Int, Sun Pharm Inds Ltd, Chartwell Life Sci, Par Pharm, Alembic Pharms Ltd, Impax Labs Inc, Sun Pharm Inds, Mylan Pharms Inc, Lannett, Mayne Pharma Inc, Hikma Intl Pharms, Mutual Pharm, Halsey, Actavis Labs Fl Inc, Pvt Form, Actavis Elizabeth, Vintage Pharms, Novel Labs Inc, Heather, Interpharm, Ivax Sub Teva Pharms, Superpharm, Caribe Holdings, Amneal Pharms Co, Ranbaxy, Medicis, Epic Pharma Llc, Pliva, Larken Labs, Amneal Pharms, Warner Chilcott, and Prinston Inc, and is included in seventy-seven NDAs. It is available from thirty-six 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-three suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.

Summary for NDA: 065356

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

Suppliers and Packaging for NDA: 065356

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXYCYCLINE
doxycycline
TABLET;ORAL 065356 ANDA Ranbaxy Pharmaceuticals Inc. 63304-130 63304-130-10 1000 TABLET, FILM COATED in 1 BOTTLE (63304-130-10)
DOXYCYCLINE
doxycycline
TABLET;ORAL 065356 ANDA Ranbaxy Pharmaceuticals Inc. 63304-131 63304-131-01 100 TABLET, FILM COATED in 1 BOTTLE (63304-131-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:May 31, 2006TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 75MG BASE
Approval Date:May 31, 2006TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:May 31, 2006TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

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Harvard Business School
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