Naproxen Oral Suspension

Brand(s)
Naprosyn
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Genentech, Inc. (2013-04-05)
Oldest Current Product
1987-03-23
License(s)
NDA, ANDA
RxNORM
ORAL SUSPENSION\NAPROXEN
FDAOB
ORAL\SUSPENSION\NAPROXEN
SPL Active
ORAL\SUSPENSION\NAPROXEN
SPL Moiety
ORAL\SUSPENSION\NAPROXEN

product(s) by strength(s)

naproxen 25 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000040028NaprosynNDAGenentech, Inc.1987-03-23NAPROXENORALSUSPENSIONNDA01896568848217-03c9-4377-9be6-6f567e629129

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1681340363ANDAPalmetto Pharmaceuticals2013-06-25NAPROXENORALSUSPENSIONANDA07419011b45955-a198-4668-b623-c010accd2618

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA074190NAPROXENROXANE LABORATORIES INC1994-03-30ANDA074190_001
2NDA018965NAPROSYNPEDIAPHARM INC1987-03-23NDA018965_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074190_001RXNAPROXEN (25MG/ML)ORALSUSPENSIONFalseAB1994-03-30NAPROXEN
2NDA018965_001RXNAPROXEN (25MG/ML)ORALSUSPENSIONTrueAB1987-03-23NAPROSYN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
111b45955-a198-4668-b623-c010accd2618 (view SPL)NAPROXEN Oral Suspension USP, 125 mg per 5 mLprescriptionHuman PrescriptionPalmetto PharmaceuticalsAPI MANUFACTURE, MANUFACTURE2013-10-013681340363
268848217-03c9-4377-9be6-6f567e629129 (view SPL)EC-NAPROSYN (naproxen delayed-release tablets) NAPROSYN (naproxen tablets) ANAPROX/ANAPROX DS (naproxen sodium tablets) NAPROSYN (naproxen suspension)prescriptionHuman PrescriptionGenentech, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2013-04-0518000040028, 000046202, 000046203, 000046313, 000046314, 000046316, 000046415, 000046416Naproxen Delayed Release Oral Tablet
Naproxen Oral Tablet

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