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Generated: May 25, 2017

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Details for New Drug Application (NDA): 065225

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NDA 065225 describes AZITHROMYCIN, which is a drug marketed by Hospira, Lupin Ltd, Gland Pharma Ltd, Wockhardt, Sagent Strides, Apotex Corp, Teva Parenteral, Sandoz, Pliva, Teva Pharms, Sun Pharm Inds Ltd, Mylan Labs Ltd, Teva, Mylan, Pliva Hrvatska Doo, Fresenius Kabi Usa, and Aurobindo Pharma Ltd, and is included in thirty-five NDAs. It is available from fifty suppliers. Additional details are available on the AZITHROMYCIN profile page.

The generic ingredient in AZITHROMYCIN is azithromycin. There are thirty-one drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the azithromycin profile page.

Summary for NDA: 065225

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

Pharmacology for NDA: 065225

Ingredient-typeMacrolides

Suppliers and Packaging for NDA: 065225

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN
azithromycin
TABLET;ORAL 065225 ANDA Medsource Pharmaceuticals 45865-536 45865-536-06 1 BLISTER PACK in 1 BOX (45865-536-06) > 6 TABLET, FILM COATED in 1 BLISTER PACK
AZITHROMYCIN
azithromycin
TABLET;ORAL 065225 ANDA A-S Medication Solutions 50090-1788 50090-1788-0 1 BLISTER PACK in 1 CARTON (50090-1788-0) > 6 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Nov 14, 2005TE:ABRLD:No


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