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Details for New Drug Application (NDA): 206323

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NDA 206323 describes CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE, which is a drug marketed by Spriaso Llc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE profile page.

The generic ingredient in CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE is chlorpheniramine maleate; codeine phosphate. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the chlorpheniramine maleate; codeine phosphate profile page.

Summary for NDA: 206323

Pharmacology for NDA: 206323

Suppliers and Packaging for NDA: 206323

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE
chlorpheniramine maleate; codeine phosphate
TABLET, EXTENDED RELEASE;ORAL 206323 NDA Nexgen Pharma, Inc. 0722-7184 0722-7184-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0722-7184-01)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength8MG;54.3MG
Approval Date:Jun 22, 2015TE:RLD:No
Patent:9,107,921Patent Expiration:Jan 3, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:6,248,363Patent Expiration:Nov 23, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF COUGH AND SYMPTOMS ASSOCIATED WITH UPPER RESPIRATORY ALLERGIES OR A COMMON COLD WITH CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE ORALLY ADMINISTERED EXTENDED RELEASE TABLETS
Patent:6,383,471Patent Expiration:Apr 6, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF COUGH AND SYMPTOMS ASSOCIATED WITH UPPER RESPIRATORY ALLERGIES OR A COMMON COLD WITH CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE ORALLY ADMINISTERED EXTENDED RELEASE TABLETS


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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.

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