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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
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Dow
Cerilliant
McKinsey
US Department of Justice
Baxter
Argus Health
Deloitte
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Generated: October 19, 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 Chartwell Life Sci, Hikma Intl Pharms, Impax Labs Inc, Watson Labs, Mutual Pharm, Lupin Ltd, Halsey, Actavis Labs Fl Inc, Pvt Form, Mylan, Par Pharm, Actavis Elizabeth, Sun Pharm Inds, Vintage Pharms, Mylan Pharms Inc, Heritage Pharms Inc, Novel Labs Inc, Heather, Interpharm, Ivax Sub Teva Pharms, Mayne Pharma Inc, Superpharm, Caribe Holdings, Amneal Pharms Co, Lannett, Ranbaxy, Medicis, Epic Pharma Llc, Pliva, Larken Labs, Amneal Pharms, West-ward Pharms Int, Warner Chilcott, and Prinston Inc, and is included in fifty-one NDAs. It is available from eighty-four 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 NDA: 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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Serving leading biopharmaceutical companies globally:

Baxter
Daiichi Sankyo
Julphar
Medtronic
Cipla
Cerilliant
Harvard Business School
McKinsey
Argus Health
Johnson and Johnson

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