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Details for New Drug Application (NDA): 062142

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NDA 062142 describes DOXYCYCLINE HYCLATE, which is a drug marketed by Chartwell Life Sci, Hikma Intl Pharms, Impax Labs Inc, Watson Labs, Mutual Pharm, Halsey, Actavis Labs Fl Inc, Pvt Form, Mylan, Par Pharm, Actavis Elizabeth, Sun Pharm Inds, Vintage Pharms, Mylan Pharms Inc, Heritage Pharms Inc, Heather, Interpharm, Ivax Sub Teva Pharms, Superpharm, Blu Caribe Inc, Lannett, Ranbaxy, Medicis, Corepharma, Pliva, Larken Labs, Amneal Pharms, West-ward Pharms Int, Warner Chilcott, and Prinston Inc, and is included in forty-seven NDAs. It is available from eighty 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 suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.

Summary for NDA: 062142

Tradename:
DOXYCYCLINE HYCLATE
Applicant:
Watson Labs
Ingredient:
doxycycline hyclate
Patents:0
Therapeutic Class:Antibacterials
Dental and Oral Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No


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