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Details for New Drug Application (NDA): 065032

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NDA 065032 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, Eurohlth Intl Sarl, Sun Pharm Inds Ltd, Chartwell Life Sci, Par Pharm, Impax Labs Inc, West-ward Pharms Int, 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, Superpharm, Blu Caribe Inc, Ranbaxy, Medicis, Corepharma, Pliva, Larken Labs, Amneal Pharms, and Warner Chilcott, and is included in sixty-eight NDAs. It is available from thirty-three 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: 065032

Sandoz Inc
Therapeutic Class:Antibacterials
Dermatological Agents

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:Jun 30, 2000TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Jun 30, 2000TE:RLD:No

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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.