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Details for New Drug Application (NDA): 062500

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NDA 062500 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, Eurohlth Intl Sarl, and Warner Chilcott, and is included in forty-six NDAs. It is available from eighty-one 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-one suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.

Summary for NDA: 062500

Chartwell Life Sci
doxycycline hyclate
Therapeutic Class:Antibacterials
Dental and Oral Agents

Pharmacology for NDA: 062500


Suppliers and Packaging for NDA: 062500

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
doxycycline hyclate
CAPSULE;ORAL 062500 ANDA Alvogen, Inc. 47781-489 47781-489-50 50 CAPSULE in 1 BOTTLE (47781-489-50)
doxycycline hyclate
CAPSULE;ORAL 062500 ANDA Alvogen, Inc. 47781-490 47781-490-05 500 CAPSULE in 1 BOTTLE (47781-490-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:Sep 11, 1984TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Sep 11, 1984TE:ABRLD:No

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