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Details for New Drug Application (NDA): 078738

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NDA 078738 describes AZELASTINE HYDROCHLORIDE, which is a drug marketed by Alcon Pharma, Apotex Inc, Sun Pharma Global, Perrigo Israel, Roxane, and Breckenridge Pharms, and is included in nine NDAs. It is available from eight suppliers. Additional details are available on the AZELASTINE HYDROCHLORIDE profile page.

The generic ingredient in AZELASTINE HYDROCHLORIDE is azelastine hydrochloride. There are twelve drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.

Summary for NDA: 078738

Pharmacology for NDA: 078738

Suppliers and Packaging for NDA: 078738

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
azelastine hydrochloride
SOLUTION/DROPS;OPHTHALMIC 078738 ANDA Sun Pharma Global FZE 47335-938 47335-938-90 1 BOTTLE, PLASTIC in 1 BOX (47335-938-90) > 6 mL in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.05%
Approval Date:Jun 21, 2010TE:ATRLD: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.