Chlorpheniramine / Codeine Extended Release Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Nexgen Pharma, Inc. (2015-06-23)
Oldest Current Product
2015-09-01
License(s)
NDA
RxNORM
EXTENDED RELEASE ORAL TABLET\CHLORPHENIRAMINE:CODEINE
FDAOB
ORAL\TABLET, EXTENDED RELEASE\CHLORPHENIRAMINE MALEATE: CODEINE PHOSPHATE
SPL Active
ORAL\TABLET, EXTENDED RELEASE\CHLORPHENIRAMINE MALEATE: CODEINE PHOSPHATE
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\CHLORPHENIRAMINE: CODEINE ANHYDROUS

product(s) by strength(s)

12 hr chlorpheniramine maleate 8 mg / codeine phosphate 54.3 mg extended release oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007227184NDANexgen Pharma, Inc.2015-09-01CHLORPHENIRAMINE MALEATE, CODEINE PHOSPHATEORALTABLET, EXTENDED RELEASENDA206323f3114cff-d638-4562-9e11-88130677363c

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA206323CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATESPRIASO LLC2015-06-22p6383471, 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, SUBSTANCE
p9066942, 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
p9107921, SUBSTANCE
p6248363, 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, SUBSTANCE
NDA206323_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA206323_001RXCHLORPHENIRAMINE MALEATE (8MG), CODEINE PHOSPHATE (54.3MG)ORALTABLET, EXTENDED RELEASEFalse2015-06-22CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE

patent(s)

#idexpiration dateapplication(s)
1p6248363 (view patent)2019-11-23NDA206323
2p6383471 (view patent)2019-04-06NDA206323
3p9066942 (view patent)2032-01-03NDA206323
4p9107921 (view patent)2032-01-03NDA206323

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1f3114cff-d638-4562-9e11-88130677363c (view SPL)These highlights do not include all the information needed to use CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE ER TABLETS safely and effectively. See full prescribing information for CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE ER TABLETS. CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE ER TABLETS, CIII Initial U.S. Approval: 1985prescriptionHuman PrescriptionNexgen Pharma, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-06-231007227184

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII