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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090431

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NDA 090431 describes DOXYCYCLINE HYCLATE, which is a drug marketed by Pliva, Medicis, Actavis Labs Fl Inc, 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, 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, Larken Labs, Lupin Ltd, Mayne Pharma Inc, Novel Labs Inc, Vintage Pharms, and Zydus Pharms Usa Inc, and is included in fifty-two NDAs. It is available from eighty-five 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-four suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.

Summary for 090431

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antibacterials
Dental and Oral Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 090431

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXYCYCLINE HYCLATE doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 090431 ANDA Mylan Pharmaceuticals Inc. 0378-4531 0378-4531-91 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-4531-91)
DOXYCYCLINE HYCLATE doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 090431 ANDA Mylan Pharmaceuticals Inc. 0378-4532 0378-4532-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-4532-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 75MG BASE
Approval Date:Dec 28, 2010TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 100MG BASE
Approval Date:Dec 28, 2010TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 50MG BASE
Approval Date:May 23, 2016TE:ABRLD:No
Regulatory Exclusivity Expiration:Nov 19, 2016
Regulatory Exclusivity Use:PATENT CHALLENGE


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