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Serving 500+ biopharmaceutical companies globally:

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Colorcon
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Generated: June 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065053

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NDA 065053 describes DOXYCYCLINE, which is a drug marketed by Heritage Pharms Inc, Mylan Labs Ltd, Zydus Pharms Usa Inc, Mylan, Sandoz Inc, Lupin Ltd, Watson Labs, G And W Labs Inc, West-ward Pharms Int, Sun Pharm Inds Ltd, Chartwell Life Sci, Par Pharm, Impax Labs Inc, Sun Pharm Inds, Mylan Pharms Inc, Lannett, Hikma Intl Pharms, Mutual Pharm, Halsey, Actavis Labs Fl Inc, Pvt Form, Actavis Elizabeth, Vintage Pharms, Heather, Interpharm, Ivax Sub Teva Pharms, Mayne Pharma Inc, Superpharm, Caribe Holdings, Ranbaxy, Medicis, Epic Pharma Llc, Pliva, Larken Labs, Amneal Pharms, Warner Chilcott, and Prinston Inc, and is included in seventy NDAs. It is available from thirty-four suppliers. Additional details are available on the DOXYCYCLINE profile page.

The generic ingredient in DOXYCYCLINE is doxycycline hyclate. There are twenty-seven drug master file entries for this compound. Ninety suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.

Summary for NDA: 065053

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antibacterials
Dermatological Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 065053

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXYCYCLINE
doxycycline
CAPSULE;ORAL 065053 ANDA Ranbaxy Pharmaceuticals Inc. 63304-614 63304-614-01 100 CAPSULE in 1 BOTTLE (63304-614-01)
DOXYCYCLINE
doxycycline
CAPSULE;ORAL 065053 ANDA Ranbaxy Pharmaceuticals Inc. 63304-614 63304-614-05 500 CAPSULE in 1 BOTTLE (63304-614-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:Nov 22, 2000TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Nov 22, 2000TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:Sep 10, 2003TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Deloitte
Citi
Covington
Colorcon
Teva
Moodys
Harvard Business School
US Department of Justice

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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