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Generated: August 20, 2018

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Details for New Drug Application (NDA): 207289

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NDA 207289 describes DOXYCYCLINE HYCLATE, which is a drug marketed by Pliva, Medicis, Actavis Labs Fl Inc, 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 Usa Inc, 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 Co Inc, Larken Labs, Lupin Ltd, Mayne Pharma Inc, Novel Labs Inc, and Vintage Pharms, and is included in fifty-three NDAs. It is available from ninety 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-eight suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 207289
Tradename:DOXYCYCLINE HYCLATE
Applicant:Amneal Pharms
Ingredient:doxycycline hyclate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207289
Ingredient-typeTetracyclines
Suppliers and Packaging for NDA: 207289
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXYCYCLINE HYCLATE doxycycline hyclate CAPSULE;ORAL 207289 ANDA Unit Dose Services 50436-1100 N 50436-1100-1
DOXYCYCLINE HYCLATE doxycycline hyclate CAPSULE;ORAL 207289 ANDA NuCare Pharmaceuticals,Inc. 68071-4354 N 68071-4354-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Jun 27, 2016TE:ABRLD:No

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