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Last Updated: February 26, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 062676


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NDA 062676 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, 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, and Vintage Pharms, and is included in fifty-nine NDAs. It is available from sixty 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-one suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 062676
Tradename:DOXYCYCLINE HYCLATE
Applicant:Sun Pharm Industries
Ingredient:doxycycline hyclate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 062676
Suppliers and Packaging for NDA: 062676
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXYCYCLINE HYCLATE doxycycline hyclate CAPSULE;ORAL 062676 ANDA Medsource Pharmaceuticals 45865-444 45865-444-14 14 CAPSULE in 1 BOTTLE, PLASTIC (45865-444-14)
DOXYCYCLINE HYCLATE doxycycline hyclate CAPSULE;ORAL 062676 ANDA AvPAK 50268-277 50268-277-15 50 BLISTER PACK in 1 BOX (50268-277-15) > 1 CAPSULE in 1 BLISTER PACK (50268-277-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Jul 10, 1986TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:Jul 10, 1986TE:ABRLD:No

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