FDA.report

Application 078250

Type
ANDA
Sponsor
GLENMARK GENERICS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001NAPROXENNAPROXENTABLET;ORAL250MGNoNo
002NAPROXENNAPROXENTABLET;ORAL375MGNoNo
003NAPROXENNAPROXENTABLET;ORAL500MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0179-1978NaproxenNaproxenKAISER FOUNDATION HOSPITALSANDACurrent
10544-277NaproxenNaproxenBlenheim Pharmacal, Inc.ANDACurrent
10544-278NaproxenNaproxenBlenheim Pharmacal, Inc.ANDACurrent
12634-684NaproxenNaproxenApotheca Inc.ANDACurrent
42254-158NaproxenNaproxenRebel Distributors CorpANDACurrent
42254-221NaproxenNaproxenRebel Distributors CorpANDACurrent
45865-610NaproxenNaproxenMedsource PharmaceuticalsANDACurrent
45865-610NaproxenNaproxenMedsource PharmaceuticalsANDACurrent
49999-049NaproxenNaproxenLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-049NaproxenNaproxenLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-049NaproxenNaproxenLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-049NaproxenNaproxenLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-0481NaproxenNaproxenA-S Medication SolutionsANDACurrent
50090-0481NaproxenNaproxenA-S Medication SolutionsANDACurrent
50090-0482NaproxenNaproxenA-S Medication SolutionsANDACurrent
50090-0482NaproxenNaproxenA-S Medication SolutionsANDACurrent
50090-0483NaproxenNaproxenA-S Medication SolutionsANDACurrent
50090-0483NaproxenNaproxenA-S Medication SolutionsANDACurrent
50090-0483NaproxenNaproxenA-S Medication SolutionsANDACurrent
50090-0483NaproxenNaproxenA-S Medication SolutionsANDACurrent
50090-1583NaproxenNaproxenA-S Medication SolutionsANDACurrent
50090-1583NaproxenNaproxenA-S Medication SolutionsANDACurrent
50090-1583NaproxenNaproxenA-S Medication SolutionsANDACurrent
50090-1583NaproxenNaproxenA-S Medication SolutionsANDACurrent
50090-1583NaproxenNaproxenA-S Medication SolutionsANDACurrent
50090-1583NaproxenNaproxenA-S Medication SolutionsANDACurrent
50090-1584NaproxenNaproxenA-S Medication SolutionsANDACurrent
50090-1584NaproxenNaproxenA-S Medication SolutionsANDACurrent
50090-1584NaproxenNaproxenA-S Medication SolutionsANDACurrent
50090-1585NaproxenNaproxenA-S Medication SolutionsANDACurrent
50090-1585NaproxenNaproxenA-S Medication SolutionsANDACurrent
50090-1585NaproxenNaproxenA-S Medication SolutionsANDACurrent
50090-2788NaproxenNaproxenA-S Medication SolutionsANDACurrent
50436-0188NaproxenNaproxenUnit Dose ServicesANDACurrent
50436-0190NaproxenNaproxenUnit Dose ServicesANDACurrent
50436-6608NaproxenNaproxenUnit Dose ServicesANDACurrent
51655-626NaproxenNaproxenNorthwind PharmaceuticalsANDACurrent
51655-685Naproxen SodiumNaproxen SodiumNorthwind Pharmaceuticals, LLCANDACurrent
52959-191NaproxenNaproxenH.J. Harkins Company, Inc.ANDACurrent
52959-271Naproxen SodiumNaproxenH.J. Harkins Company, Inc.ANDACurrent
53002-3111NaproxenNaproxenRPK Pharmaceuticals, Inc.ANDACurrent
53002-3111NaproxenNaproxenRPK Pharmaceuticals, Inc.ANDACurrent
53002-3241NaproxenNaproxenRPK Pharmaceuticals, Inc.ANDACurrent
53217-262NaproxenNaproxenAidarex Pharmaceuticals LLCANDACurrent
53808-0386NaproxenNaproxenState of Florida DOH Central PharmacyANDACurrent
58118-0199NaproxenNaproxenClinical Solutions Wholesale, LLCANDACurrent
58118-0199NaproxenNaproxenClinical Solutions Wholesale, LLCANDACurrent
58118-0199NaproxenNaproxenClinical Solutions Wholesale, LLCANDACurrent
58118-0199NaproxenNaproxenClinical Solutions Wholesale, LLCANDACurrent
60687-491NaproxenNaproxenAmerican Health PackagingANDACurrent
60687-491NaproxenNaproxenAmerican Health PackagingANDACurrent
60687-491NaproxenNaproxenAmerican Health PackagingANDACurrent
60760-140NaproxenNaproxenSt. Mary's Medical Park PharmacyANDACurrent
60760-140NaproxenNaproxenSt. Mary's Medical Park PharmacyANDACurrent
60760-190NaproxenNaproxenSt. Mary's Medical Park PharmacyANDACurrent
60760-190NaproxenNaproxenSt. Mary's Medical Park PharmacyANDACurrent
60760-190NaproxenNaproxenSt. Mary's Medical Park PharmacyANDACurrent
61919-162NAPROXENNAPROXENDIRECT RXANDACurrent
61919-162NAPROXENNAPROXENDIRECT RXANDACurrent
61919-162NAPROXENNAPROXENDIRECT RXANDACurrent
61919-173NAPROXENNAPROXEN SODIUMDIRECT RXANDACurrent
61919-173NAPROXENNAPROXEN SODIUMDIRECT RXANDACurrent
61919-376NAPROXENNAPROXENDirect_RxANDACurrent
61919-376NAPROXENNAPROXENDirect_RxANDACurrent
61919-376NAPROXENNAPROXENDirect_RxANDACurrent
61919-376NAPROXENNAPROXENDirect_RxANDACurrent
61919-376NAPROXENNAPROXENDirect_RxANDACurrent
61919-376NAPROXENNAPROXENDirect_RxANDACurrent
63187-028NaproxenNaproxenProficient Rx LPANDACurrent
63187-028NaproxenNaproxenProficient Rx LPANDACurrent
63187-028NaproxenNaproxenProficient Rx LPANDACurrent
63187-028NaproxenNaproxenProficient Rx LPANDACurrent
63187-461NaproxenNaproxenProficient Rx LPANDACurrent
63187-461NaproxenNaproxenProficient Rx LPANDACurrent
63187-461NaproxenNaproxenProficient Rx LPANDACurrent
63187-535NaproxenNaproxenProficient Rx LPANDACurrent
63187-535NaproxenNaproxenProficient Rx LPANDACurrent
63629-6657NaproxenNaproxenBryant Ranch PrepackANDACurrent
63874-301NaproxenNaproxenAltura Pharmaceuticals, Inc.ANDACurrent
63874-325NaproxenNaproxenAltura Pharmaceuticals, Inc.ANDACurrent