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Serving leading biopharmaceutical companies globally:

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Harvard Business School
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Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078208

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NDA 078208 describes NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE, which is a drug marketed by Akorn Inc and Altaire Pharms Inc and is included in two NDAs. It is available from five suppliers. Additional details are available on the NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE profile page.

The generic ingredient in NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE is naphazoline hydrochloride; pheniramine maleate. There are six drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the naphazoline hydrochloride; pheniramine maleate profile page.
Summary for 078208
Suppliers and Packaging for NDA: 078208
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE naphazoline hydrochloride; pheniramine maleate SOLUTION/DROPS;OPHTHALMIC 078208 ANDA Altaire Pharmaceuticals Inc. 59390-177 N 59390-177-13

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SOLUTION/DROPS;OPHTHALMICStrength0.02675%;0.315%
Approval Date:Sep 27, 2010TE:RLD:No

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