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Generated: November 19, 2018

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Details for New Drug Application (NDA): 202520

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NDA 202520 describes POLMON, which is a drug marketed by Capellon Pharms Llc and is included in one NDA. It is available from two suppliers. Additional details are available on the POLMON profile page.

The generic ingredient in POLMON is dexchlorpheniramine maleate. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dexchlorpheniramine maleate profile page.
Summary for 202520
Tradename:POLMON
Applicant:Capellon Pharms Llc
Ingredient:dexchlorpheniramine maleate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 202520
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POLMON dexchlorpheniramine maleate SYRUP;ORAL 202520 ANDA CARWIN PHARMACEUTICAL ASSOCIATES, LLC 15370-150 15370-150-04 118 mL in 1 BOTTLE, PLASTIC (15370-150-04)
POLMON dexchlorpheniramine maleate SYRUP;ORAL 202520 ANDA CARWIN PHARMACEUTICAL ASSOCIATES, LLC 15370-150 15370-150-16 473 mL in 1 BOTTLE, PLASTIC (15370-150-16)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength2MG/5ML
Approval Date:Jul 16, 2018TE:AARLD:No

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