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Serving hundreds of leading biopharmaceutical companies globally:

Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 062677

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NDA 062677 describes DOXYCYCLINE HYCLATE, which is a drug marketed by Pliva, Medicis, Actavis Labs Fl Inc, Amneal Pharms, Chartwell Life Sci, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Mylan, Par Pharm, Pvt Form, Ranbaxy, Sun Pharm Industries, Superpharm, Warner Chilcott, Watson Labs, West-ward Pharms Int, Actavis Elizabeth, Heritage Pharms Inc, Impax Labs Inc, Mylan Pharms Inc, Prinston Inc, Amneal Pharms Co, Caribe Holdings, Epic Pharma Llc, Ivax Sub Teva Pharms, Lannett, Larken Labs, Lupin Ltd, Mayne Pharma Inc, Novel Labs Inc, Vintage Pharms, and Zydus Pharms Usa Inc, and is included in fifty-two NDAs. It is available from eighty-seven suppliers. Additional details are available on the DOXYCYCLINE HYCLATE profile page.

The generic ingredient in DOXYCYCLINE HYCLATE is doxycycline hyclate. There are twenty-seven 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 062677

Tradename:	DOXYCYCLINE HYCLATE
Applicant:	Sun Pharm Industries
Ingredient:	doxycycline hyclate
Patents:	0
Therapeutic Class:	Antibacterials Dental and Oral Agents
Formulation / Manufacturing:	see details

Pharmacology for NDA: 062677

Ingredient-type	Tetracyclines

Suppliers and Packaging for NDA: 062677

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET;ORAL	062677	ANDA	Aphena Pharma Solutions - Tennessee, LLC	43353-923	N	43353-923-65
DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET;ORAL	062677	ANDA	Aphena Pharma Solutions - Tennessee, LLC	43353-923	N	43353-923-20

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 100MG BASE
Approval Date:	Jul 10, 1986	TE:	AB	RLD:	No

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