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Last Updated: October 31, 2024

Details for New Drug Application (NDA): 061837


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NDA 061837 describes TETRACYCLINE HYDROCHLORIDE, which is a drug marketed by Abbott, Amneal Pharms Ny, Ani Pharms, Aurobindo Pharma Usa, Breckenridge, Chartwell Tetra, Elkins Sinn, Ferrante, Heather, Hikma, Impax Labs, Ivax Sub Teva Pharms, Mast Mm, Purepac Pharm, Pvt Form, Roxane, Strides Pharma, Sun Pharm Industries, Superpharm, Valeant Pharm Intl, Warner Chilcott, Watson Labs, Wyeth Ayerst, Alpharma Us Pharms, and Proter, and is included in twenty-nine NDAs. It is available from seven suppliers. Additional details are available on the TETRACYCLINE HYDROCHLORIDE profile page.

The generic ingredient in TETRACYCLINE HYDROCHLORIDE is tetracycline hydrochloride. There are ninety-nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the tetracycline hydrochloride profile page.
Summary for 061837
Tradename:TETRACYCLINE HYDROCHLORIDE
Applicant:Watson Labs
Ingredient:tetracycline hydrochloride
Patents:0
Pharmacology for NDA: 061837
Suppliers and Packaging for NDA: 061837
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TETRACYCLINE HYDROCHLORIDE tetracycline hydrochloride CAPSULE;ORAL 061837 ANDA Actavis Pharma, Inc. 0591-2474 0591-2474-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0591-2474-01)
TETRACYCLINE HYDROCHLORIDE tetracycline hydrochloride CAPSULE;ORAL 061837 ANDA Actavis Pharma, Inc. 0591-2475 0591-2475-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0591-2475-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength500MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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