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Last Updated: May 30, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 062269


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NDA 062269 describes DOXYCYCLINE HYCLATE, which is a drug marketed by Pliva, Medicis, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alembic Pharms Ltd, Amneal Pharms, Changzhou Pharm, 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, Zhejiang Yongtai, Zydus Pharms, West-ward Pharms Int, Actavis Elizabeth, Heritage Pharms Inc, Impax Labs Inc, Mylan Pharms Inc, Prinston Inc, Amneal Pharms Co, Apotex, Cadila, Caribe Holdings, Emcure Pharms Ltd, Epic Pharma Llc, Heritage Pharma, Lannett Co Inc, Larken Labs, Lupin Ltd, Mayne Pharma Inc, Novel Labs Inc, Oaklock Llc, and Vintage Pharms, and is included in sixty-two NDAs. It is available from sixty-one 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. Seventy-three suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 062269
Tradename:DOXYCYCLINE HYCLATE
Applicant:Caribe Holdings
Ingredient:doxycycline hyclate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 062269
Suppliers and Packaging for NDA: 062269
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXYCYCLINE HYCLATE doxycycline hyclate TABLET;ORAL 062269 ANDA PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS 24658-312 24658-312-01 100 TABLET in 1 BOTTLE (24658-312-01)
DOXYCYCLINE HYCLATE doxycycline hyclate TABLET;ORAL 062269 ANDA PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS 24658-312 24658-312-05 500 TABLET in 1 BOTTLE (24658-312-05)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Nov 8, 1982TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Oct 5, 1983TE:RLD:No

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