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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 207289


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NDA 207289 describes DOXYCYCLINE HYCLATE, which is a drug marketed by Pliva, Bausch, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alembic, Amneal Pharms, Changzhou Pharm, Chartwell, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Nesher Pharms, Nostrum Labs Inc, Par Pharm, Pvt Form, Ranbaxy, Strides Pharma, Sun Pharm Industries, Superpharm, Warner Chilcott, Watson Labs, Zhejiang Yongtai, Zydus Lifesciences, Gland Pharma Ltd, Par Sterile Products, West-ward Pharms Int, Actavis Elizabeth, Aurobindo Pharma Usa, Heritage Pharms, Impax Labs Inc, Lupin, Prinston Inc, Rising, Zydus Pharms, Acella, Amneal, Amneal Pharms Co, Apotex, Avet Lifesciences, Caribe Holdings, Chartwell Molecular, Dr Reddys Labs Sa, Epic Pharma Llc, Heritage Pharma, Larken Labs, Lupin Ltd, Mylan, Novel Labs Inc, Pharmobedient, and Praxgen, and is included in seventy-six NDAs. It is available from sixty-four 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-two 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
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 Amneal Pharmaceuticals NY LLC 60219-1100 60219-1100-1 100 CAPSULE in 1 BOTTLE (60219-1100-1)
DOXYCYCLINE HYCLATE doxycycline hyclate CAPSULE;ORAL 207289 ANDA Amneal Pharmaceuticals NY LLC 60219-1100 60219-1100-3 20 CAPSULE in 1 BOTTLE (60219-1100-3)

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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