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Details for New Drug Application (NDA): 065246

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NDA 065246 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-seven 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-three 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: 065246

Tradename:
AZITHROMYCIN
Applicant:
Pliva
Ingredient:
azithromycin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065246

Ingredient-typeMacrolides

Suppliers and Packaging for NDA: 065246

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN
azithromycin
FOR SUSPENSION;ORAL 065246 ANDA Teva Pharmaceuticals USA, Inc. 0093-2026 0093-2026-23 15 mL in 1 BOTTLE (0093-2026-23)
AZITHROMYCIN
azithromycin
FOR SUSPENSION;ORAL 065246 ANDA Teva Pharmaceuticals USA, Inc. 0093-2026 0093-2026-31 30 mL in 1 BOTTLE (0093-2026-31)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 200MG BASE/5ML
Approval Date:Jul 5, 2006TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 100MG BASE/5ML
Approval Date:Jul 5, 2006TE: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.

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