Alpron

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

73 API Suppliers, 23 USDMF, 13 CEP/COS, 1 JDMF, 3 EU WC, 33 KDMF, 12 NDC API, 1 VMF, 17 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

19 Drugs in Development

19 Drugs in Development

INTERMEDIATES

4 Intermediate Suppliers

4 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

357 FDF Dossiers, 116 FDA Orange Book, 115 Europe, 25 Canada, 25 Australia, 25 South Africa, 51 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MG, TABLET;ORAL - 375MG, TABLET;ORAL - 500MG, SUSPENSION;ORAL - 25MG/ML, TABLET, DELAYED RELEASE;ORAL - 375MG, TABLET, DELAYED RELEASE;ORAL - 500MG, TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

7 Evonik, 1 Rochem International Inc, 6 SPI Pharma, 6 DKSH, 11 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 3 Kirsch Pharma, 1 ACG Worldwide, 8 Actylis, 2 Aeon Procare, 2 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 33 BASF, 1 CD Formulation, 1 Clariant, 14 Corel Pharma Chem, 6 DFE Pharma, 3 Doshion Polyscience, 1 Esteem Industries, 2 Finar, 12 Gangwal Chemicals, 12 Ideal Cures, 4 Ingredion Pharma Solutions, 20 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 27 Roquette, 14 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 3 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

68 Coating Systems & Additives, 61 Fillers, Diluents & Binders, 39 Disintegrants & Superdisintegrants, 37 Controlled & Modified Release, 36 Solubilizers, 32 Thickeners and Stabilizers, 30 Granulation, 30 Direct Compression, 23 Film Formers & Plasticizers, 20 Taste Masking, 18 Topical, 17 Parenteral, 17 Lubricants & Glidants, 15 Co-Processed Excipients, 13 Chewable & Orodispersible Aids, 8 Emulsifying Agents, 7 Rheology Modifiers, 6 Surfactant & Foaming Agents, 6 API Stability Enhancers, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

38 News #PharmaBuzz

38 News #PharmaBuzz

GLOBAL SALES INFORMATION

20 US Medicaid Prescriptions, 65 Regulatory FDF Prices, 2 Annual Reports

MARKET PLACE

35 APIs, 3 FDF Dossiers

PATENTS & EXCLUSIVITIES

8 Health Canada Patents

8 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 41 Others

ANALYTICAL

3 BioAnalytical Methods

3 BioAnalytical Methods

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 20067 / DOSAGE - TABLET, DELAYED RELEASE;ORAL - 500MG

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	Lake Erie Medical DBA Quality Care Products LLC	A-S Medication Solutions	AvKARE, Inc.	Bryant Ranch Prepack	Cipla USA Inc.	Genentech, Inc.	medsource pharmaceuticals	PD-Rx Pharmaceuticals, Inc.	Preferred Pharmaceuticals Inc.	REMEDYREPACK INC.	TruPharma LLC
ALUMINUM OXIDE(LMI26O6933)
CROSCARMELLOSE SODIUM(M28OL1HH48)
FD&C BLUE NO. 2(L06K8R7DQK)
ferric oxide red(1K09F3G675)
FERROSOFERRIC OXIDE(XM0M87F357)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
INDIGOTINDISULFONATE SODIUM(D3741U8K7L)
MAGNESIUM STEARATE(70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)
methacrylic acid - methyl methacrylate copolymer (1:1)(74G4R6TH13)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(NX76LV5T8J)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
polyethylene glycol 8000(Q662QK8M3B)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
povidone K90(RDH86HJV5Z)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
POVIDONES(FZ989GH94E)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)
sodium hydroxide(55X04QC32I)
STARCH, CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
triethyl citrate(8Z96QXD6UM)
WATER(059QF0KO0R)

Setid 68848217 03c9 4377 9be6 6f567e629129 Applno 20067 Form Tablet Delayed Release Oral Dosage 500mg - Drug Product Composition: Alpron

Alpron

Alpron

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

73 API Suppliers

23 USDMF

13 CEP/COS

1 JDMF

3 EU WC

33 KDMF

12 NDC API

1 VMF

17 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

19 Drugs in Development

INTERMEDIATES

4 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

357 FDF Dossiers

116 FDA Orange Book

115 Europe

25 Canada

25 Australia

25 South Africa

51 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MG

TABLET;ORAL - 375MG

TABLET;ORAL - 500MG

SUSPENSION;ORAL - 25MG/ML

TABLET, DELAYED RELEASE;ORAL - 375MG

TABLET, DELAYED RELEASE;ORAL - 500MG

TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

7 Evonik

1 Rochem International Inc

6 SPI Pharma

6 DKSH

11 Boai NKY Pharmaceuticals Ltd

6 Gangwal Healthcare

6 Nanjing Well Pharmaceutical

1 Pfanstiehl

3 Kirsch Pharma

1 ACG Worldwide

8 Actylis

2 Aeon Procare

2 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

33 BASF

1 CD Formulation

1 Clariant

14 Corel Pharma Chem

6 DFE Pharma

3 Doshion Polyscience

1 Esteem Industries

2 Finar

12 Gangwal Chemicals

12 Ideal Cures

4 Ingredion Pharma Solutions

20 Kerry

3 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

12 Microlex e.U

1 Nanjing Bold Chemical

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

3 Novo Excipients

4 Pharmatrans-Sanaq

6 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;375MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons