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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 Altaire Pharms Inc and Akorn 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. Fourteen suppliers are listed for this compound. Additional details are available on the naphazoline hydrochloride; pheniramine maleate profile page.

Summary for NDA: 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 59390-177-13 15 mL in 1 BOTTLE, DROPPER (59390-177-13)

Summary 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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