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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, Teva, Mylan, Pliva Hrvatska Doo, Fresenius Kabi Usa, and Aurobindo Pharma Ltd, and is included in thirty-four NDAs. It is available from forty-five suppliers. Additional details are available on the AZITHROMYCIN profile page.

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

Summary for NDA: 065225

Therapeutic Class:Antibacterials

Pharmacology for NDA: 065225


Suppliers and Packaging for NDA: 065225

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
TABLET;ORAL 065225 ANDA A-S Medication Solutions 50090-1887 50090-1887-0 1 BLISTER PACK in 1 CARTON (50090-1887-0) > 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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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.