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Last Updated: November 28, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065302

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NDA 065302 describes AZITHROMYCIN, which is a drug marketed by Amneal, Aurobindo Pharma Ltd, Epic Pharma Llc, Lupin Ltd, Pliva, Sandoz, Taro, Teva Pharms, Zydus, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hainan Poly Pharm, Hikma Pharms, Hospira, Mylan Asi, Mylan Labs Ltd, Sun Pharm Inds Ltd, Teva Parenteral, Alembic Pharms Ltd, Apotex Corp, Bionpharma Inc, Cspc Ouyi, Mylan, Sunshine, Teva, Wockhardt, and Yung Shin Pharm, and is included in fifty-seven NDAs. It is available from fifty-three suppliers. Additional details are available on the AZITHROMYCIN profile page.

The generic ingredient in AZITHROMYCIN is azithromycin. There are thirty-two 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 065302
Formulation / Manufacturing:see details
Pharmacology for NDA: 065302
Medical Subject Heading (MeSH) Categories for 065302
Suppliers and Packaging for NDA: 065302
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN azithromycin TABLET;ORAL 065302 ANDA Wockhardt USA LLC. 64679-962 64679-962-01 30 TABLET, FILM COATED in 1 BOTTLE (64679-962-01)
AZITHROMYCIN azithromycin TABLET;ORAL 065302 ANDA Wockhardt USA LLC. 64679-962 64679-962-03 1400 TABLET, FILM COATED in 1 POUCH (64679-962-03)

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 600MG BASE
Approval Date:Feb 11, 2008TE:ABRLD:No

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