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Generated: August 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065287

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NDA 065287 describes DOXYCYCLINE HYCLATE, which is a drug marketed by Chartwell Life Sci, Hikma Intl Pharms, Impax Labs Inc, Watson Labs, Mutual Pharm, Halsey, Actavis Labs Fl Inc, Pvt Form, Mylan, Par Pharm, Actavis Elizabeth, Sun Pharm Inds, Vintage Pharms, Mylan Pharms Inc, Heritage Pharms Inc, Heather, Interpharm, Ivax Sub Teva Pharms, Mayne Pharma Inc, Superpharm, Caribe Holdings, Lannett, Ranbaxy, Medicis, Epic Pharma Llc, Pliva, Larken Labs, Amneal Pharms, West-ward Pharms Int, Warner Chilcott, and Prinston Inc, and is included in forty-eight NDAs. It is available from eighty 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 suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.

Summary for NDA: 065287

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

Pharmacology for NDA: 065287

Ingredient-typeTetracyclines

Suppliers and Packaging for NDA: 065287

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXYCYCLINE HYCLATE
doxycycline hyclate
TABLET;ORAL 065287 ANDA e5 Pharma, LLC. 13517-108 13517-108-01 100 TABLET, FILM COATED in 1 BOTTLE (13517-108-01)
DOXYCYCLINE HYCLATE
doxycycline hyclate
TABLET;ORAL 065287 ANDA STI Pharma LLC 54879-025 54879-025-01 100 TABLET in 1 BOTTLE (54879-025-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Feb 28, 2006TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Express Scripts
Cerilliant
Fuji
US Department of Justice
Johnson and Johnson
UBS
Federal Trade Commission
Healthtrust
Queensland Health

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