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Last Updated: July 24, 2024

Details for New Drug Application (NDA): 211343

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NDA 211343 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, Endo Operations, Gland Pharma Ltd, Lupin Ltd, 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, Mylan, Novel Labs Inc, Pharmobedient, Praxgen, and Torrent, and is included in seventy-nine NDAs. It is available from sixty-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. Seventy-three suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 211343
Applicant:Changzhou Pharm
Ingredient:doxycycline hyclate
Formulation / Manufacturing:see details
Pharmacology for NDA: 211343
Suppliers and Packaging for NDA: 211343
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXYCYCLINE HYCLATE doxycycline hyclate TABLET;ORAL 211343 ANDA Tris Pharma Inc 27808-234 27808-234-01 50 TABLET in 1 BOTTLE (27808-234-01)
DOXYCYCLINE HYCLATE doxycycline hyclate TABLET;ORAL 211343 ANDA Tris Pharma Inc 27808-234 27808-234-02 500 TABLET in 1 BOTTLE (27808-234-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Oct 9, 2019TE:ABRLD:No

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