Naproxen Sodium

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ACTIVE PHARMA INGREDIENTS

31 API Suppliers, 22 USDMF, 8 CEP/COS, 5 EU WC, 34 KDMF, 11 NDC API, 9 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

FINISHED DOSAGE FORMULATIONS

152 FDF Dossiers, 85 FDA Orange Book, 11 Europe, 18 Canada, 4 South Africa, 34 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 500MG BASE, TABLET;ORAL - 220MG, TABLET, EXTENDED RELEASE;ORAL - EQ 375MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 500MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 750MG BASE, CAPSULE;ORAL - EQ 200MG BASE, TABLET;ORAL - 500MG;EQ 85MG BASE, TABLET;ORAL - 60MG;EQ 10MG BASE

RELATED EXCIPIENT COMPANIES

3 Evonik, 4 Rochem International Inc, 19 SPI Pharma, 2 Seqens, 9 DKSH, 8 Faran Shimi Pharmaceutical, 11 Boai NKY Pharmaceuticals Ltd, 14 Gangwal Healthcare, 11 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 11 Actylis, 2 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 33 BASF, 3 Clariant, 17 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 13 Gangwal Chemicals, 11 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 33 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 20 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 4 Pharmatrans-Sanaq, 9 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 38 Roquette, 13 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

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USFDA APPLICATION NUMBER - 18164 / DOSAGE - TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
naproxen sodium(UNII: 9TN87S3A3C) (naproxen - UNII:57Y76R9ATQ)	naproxen sodium	550mg
naproxen(UNII: 57Y76R9ATQ) (naproxen - UNII:57Y76R9ATQ)	naproxen	500mg \| 375mg \| 500mg

Inactive Ingredients

Ingredient Name	Genentech, Inc.
croscarmellose sodium(M28OL1HH48)
ferric oxide red(1K09F3G675)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
magnesium stearate(70097M6I30)
methacrylic acid - methyl methacrylate copolymer (1:1)(74G4R6TH13)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
polyethylene glycol 8000(Q662QK8M3B)
povidone K90(RDH86HJV5Z)
POVIDONE, UNSPECIFIED(FZ989GH94E)
sodium hydroxide(55X04QC32I)
talc(7SEV7J4R1U)
triethyl citrate(8Z96QXD6UM)
water(059QF0KO0R)

Drug Product Composition: Naproxen Sodium

Naproxen Sodium

Naproxen Sodium

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

31 API Suppliers

22 USDMF

8 CEP/COS

5 EU WC

34 KDMF

11 NDC API

9 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

FINISHED DOSAGE FORMULATIONS

152 FDF Dossiers

85 FDA Orange Book

11 Europe

18 Canada

4 South Africa

34 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 500MG BASE

TABLET;ORAL - 220MG

TABLET, EXTENDED RELEASE;ORAL - EQ 375MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 500MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 750MG BASE

CAPSULE;ORAL - EQ 200MG BASE

TABLET;ORAL - 500MG;EQ 85MG BASE

TABLET;ORAL - 60MG;EQ 10MG BASE

RELATED EXCIPIENT COMPANIES

3 Evonik

4 Rochem International Inc

19 SPI Pharma

2 Seqens

9 DKSH

8 Faran Shimi Pharmaceutical

11 Boai NKY Pharmaceuticals Ltd

14 Gangwal Healthcare

11 Nanjing Well Pharmaceutical

2 Pfanstiehl

4 ACG Worldwide

11 Actylis

2 Aeon Procare

1 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

33 BASF

3 Clariant

17 Corel Pharma Chem

6 DFE Pharma

2 Finar

13 Gangwal Chemicals

11 Ideal Cures Pvt Ltd

5 Ingredion Pharma Solutions

33 Kerry

4 Kima Chemical

6 Lonza Capsugel

20 Microlex e.U

1 Nanjing Bold Chemical

2 Nomisma Healthcare

4 Novo Excipients

4 Pharmatrans-Sanaq

9 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

38 Roquette

13 Seppic

7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

2 Shijiazhuang Huaxu Pharmaceutical

12 Sigachi Industries

3 The Dow Chemical Company

3 Ulanqab Kema New Material

1 Valens Pharmachem

TABLET;ORAL - EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons