Naproxen / Pseudoephedrine Extended Release Oral Tablet

Brand(s)
Sudafed Sinus & Pain
Category(s)
otc
SPL Type(s)
Human OTC
Master SPL
Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division (2015-09-03)
Oldest Current Product
2010-11-01
License(s)
ANDA
RxNORM
EXTENDED RELEASE ORAL TABLET\NAPROXEN:PSEUDOEPHEDRINE
FDAOB
ORAL\TABLET, EXTENDED RELEASE\NAPROXEN SODIUM: PSEUDOEPHEDRINE HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\NAPROXEN SODIUM: PSEUDOEPHEDRINE HYDROCHLORIDE
ORAL\TABLET, FILM COATED\NAPROXEN SODIUM: PSEUDOEPHEDRINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\NAPROXEN: PSEUDOEPHEDRINE
ORAL\TABLET, FILM COATED\NAPROXEN: PSEUDOEPHEDRINE

product(s) by strength(s)

12 hr naproxen sodium 220 mg / pseudoephedrine hydrochloride 120 mg extended release oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003630650ANDAWalgreens2013-05-23NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA076518b0417ce5-3a5e-42cb-8672-9f2b133c91ca
2116730417ANDATarget Corp2013-08-30NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0765180922e52f-e2f6-4f79-886a-f3ce4a9e4b96
3301420417ANDAKroger2013-08-21NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA076518c3a5c7f6-025d-4f98-bbe4-a165fc0b17c3
4368000417ANDATop Care (Topco Associates Llc)2013-08-14NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA07651855c177ce-1729-4a9b-a5ae-2b6c96fbc27a
5412500417ANDAMeijer Distribution, Inc2013-08-12NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA076518cb78330b-d8a3-4c16-bbb0-d31368a542e6
6425070417ANDAHy-Vee2013-08-12NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA076518b8dc7343-8ad5-46ad-8088-2165c7c20b6b
7461220197ANDAAmerisource Bergen2013-08-22NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA076518a622259a-7530-4ca8-9eb5-4e02857a28f3
8493480393ANDASunmark2013-08-15NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA076518c09e8374-aa5c-4a0d-9073-58bf63a2e201
9505800539Sudafed Sinus & PainANDAJohnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division2010-11-01NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA076518be68ca89-6757-4f30-8cbc-da6b95eed2c9
10597790417ANDACvs2013-08-15NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA07651848ab6f9f-fc15-4a7b-85e9-a87639396f80
11620110204ANDAMckesson (Health Mart)2013-08-15NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA07651820932ad4-6c1c-4b44-94fe-60b9c4ab0a93

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA076518NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDEL PERRIGO CO2004-03-17ANDA076518_001
2ANDA077381NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDEDR REDDYS LABORATORIES INC2006-09-27ANDA077381_001
3NDA021076ALEVE-D SINUS & COLDBAYER HEALTHCARE LLC1999-11-29NDA021076_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA076518_001OTCNAPROXEN SODIUM (EQ 200MG BASE), PSEUDOEPHEDRINE HYDROCHLORIDE (120MG)ORALTABLET, EXTENDED RELEASEFalse2004-03-17NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE
2ANDA077381_001OTCNAPROXEN SODIUM (EQ 220MG BASE), PSEUDOEPHEDRINE HYDROCHLORIDE (120MG)ORALTABLET, EXTENDED RELEASEFalse2006-09-27NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE
3NDA021076_001OTCPSEUDOEPHEDRINE HYDROCHLORIDE (120MG), NAPROXEN SODIUM (200MG)ORALTABLET, EXTENDED RELEASETrue1999-11-29ALEVE-D SINUS & COLD

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
10922e52f-e2f6-4f79-886a-f3ce4a9e4b96 (view SPL)Target Corporation Sinus and Cold-D Drug FactsotcHuman OTCTarget Corp2015-04-132116730417
220932ad4-6c1c-4b44-94fe-60b9c4ab0a93 (view SPL)McKesson Sinus & Cold-D Drug FactsotcHuman OTCMckesson (Health Mart)2013-09-171620110204
348ab6f9f-fc15-4a7b-85e9-a87639396f80 (view SPL)CVS Pharmacy, Inc. Sinus & Cold - D Drug FactsotcHuman OTCCvs2015-07-082597790417
455c177ce-1729-4a9b-a5ae-2b6c96fbc27a (view SPL)Topco Associates LLC. Sinus & Cold-D Drug FactsotcHuman OTCTop Care (Topco Associates Llc)2013-09-181368000417
5a622259a-7530-4ca8-9eb5-4e02857a28f3 (view SPL)Amerisource Bergen Sinus & Cold-D Drug FactsotcHuman OTCAmerisource Bergen2013-09-171461220197
6b0417ce5-3a5e-42cb-8672-9f2b133c91ca (view SPL)Walgreen Co. All Day Sinus & Cold D Drug FactsotcHuman OTCWalgreens2014-06-252003630650
7b8dc7343-8ad5-46ad-8088-2165c7c20b6b (view SPL)Hy-Vee, Inc. All Day Sinus & Cold-D Drug FactsotcHuman OTCHy-Vee2013-09-161425070417
8be68ca89-6757-4f30-8cbc-da6b95eed2c9 (view SPL)SUDAFED 12 HOUR PRESSURE+PAINotcHuman OTCJohnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division2015-09-033505800539
9c09e8374-aa5c-4a0d-9073-58bf63a2e201 (view SPL)McKesson Sinus & Cold-D Drug FactsotcHuman OTCSunmark2013-09-171493480393
10c3a5c7f6-025d-4f98-bbe4-a165fc0b17c3 (view SPL)Kroger Co. Sinus & Cold-D Drug FactsotcHuman OTCKroger2013-09-181301420417
11cb78330b-d8a3-4c16-bbb0-d31368a542e6 (view SPL)Meijer Distribution, Inc. Sinus & Cold-D Drug FactsotcHuman OTCMeijer Distribution, Inc2013-09-201412500417

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