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Generated: June 24, 2019

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Details for New Drug Application (NDA): 065277

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NDA 065277 describes DOXYCYCLINE HYCLATE, which is a drug marketed by Pliva, Medicis, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alembic Pharms Ltd, 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, Zydus Pharms, West-ward Pharms Int, Actavis Elizabeth, Heritage Pharms Inc, Impax Labs Inc, Mylan Pharms Inc, Prinston Inc, Amneal Pharms Co, Apotex Inc, Cadila, Caribe Holdings, Emcure Pharms Ltd, Epic Pharma Llc, Heritage Pharma, Lannett Co Inc, Larken Labs, Lupin Ltd, Mayne Pharma Inc, Novel Labs Inc, and Vintage Pharms, and is included in fifty-seven NDAs. It is available from eighty-five suppliers. Additional details are available on the DOXYCYCLINE HYCLATE profile page.

The generic ingredient in DOXYCYCLINE HYCLATE is doxycycline hyclate. There are twenty-eight 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 065277
Tradename:DOXYCYCLINE HYCLATE
Applicant:Lannett Co Inc
Ingredient:doxycycline hyclate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065277
Suppliers and Packaging for NDA: 065277
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXYCYCLINE HYCLATE doxycycline hyclate TABLET;ORAL 065277 ANDA Lannett Company, Inc. 0527-1336 0527-1336-01 100 TABLET, FILM COATED in 1 BOTTLE (0527-1336-01)
DOXYCYCLINE HYCLATE doxycycline hyclate TABLET;ORAL 065277 ANDA Lannett Company, Inc. 0527-1336 0527-1336-06 60 TABLET, FILM COATED in 1 BOTTLE (0527-1336-06)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Nov 10, 2005TE:ABRLD:No

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