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Serving 500+ biopharmaceutical companies globally:

Cipla
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Generated: June 28, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203294

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NDA 203294 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 forty-eight 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-five suppliers are listed for this compound. Additional details are available on the azithromycin profile page.

Summary for NDA: 203294

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

Pharmacology for NDA: 203294

Ingredient-typeMacrolides

Suppliers and Packaging for NDA: 203294

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN
azithromycin
 INJECTABLE;INJECTION 203294 ANDA AuroMedics Pharma LLC 55150-174 55150-174-10 10 VIAL in 1 CARTON (55150-174-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Jun 19, 2015TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
UBS
Deloitte
Merck
Daiichi Sankyo
Boehringer Ingelheim
Colorcon
Johnson and Johnson
Julphar
AstraZeneca

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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