Aprovel

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

107 API Suppliers, 41 USDMF, 31 CEP/COS, 17 JDMF, 15 EU WC, 27 KDMF, 15 NDC API, 45 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

10 Drugs in Development

10 Drugs in Development

INTERMEDIATES

18 Intermediate Suppliers

18 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1014 FDF Dossiers, 118 FDA Orange Book, 629 Europe, 63 Canada, 50 Australia, 34 South Africa, 120 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 150MG, TABLET;ORAL - 300MG, TABLET;ORAL - 75MG, TABLET;ORAL - 12.5MG;150MG, TABLET;ORAL - 12.5MG;300MG, TABLET;ORAL - 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Rochem International Inc, 18 SPI Pharma, 6 DKSH, 4 Boai NKY Pharmaceuticals Ltd, 7 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 1 Pfanstiehl, 2 Kirsch Pharma, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 1 Avesta Pharma, 27 BASF, 3 Clariant, 10 Corel Pharma Chem, 7 DFE Pharma, 1 Esteem Industries, 2 Finar, 12 Gangwal Chemicals, 5 Ideal Cures, 5 Ingredion Pharma Solutions, 26 Kerry, 4 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 16 Microlex e.U, 2 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 7 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 20 Roquette, 14 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 5 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 5 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

72 Fillers, Diluents & Binders, 50 Coating Systems & Additives, 40 Direct Compression, 35 Disintegrants & Superdisintegrants, 33 Granulation, 29 Lubricants & Glidants, 29 Solubilizers, 27 Thickeners and Stabilizers, 26 Controlled & Modified Release, 23 Topical, 22 Parenteral, 19 Chewable & Orodispersible Aids, 18 Taste Masking, 16 Film Formers & Plasticizers, 15 Co-Processed Excipients, 11 Emulsifying Agents, 8 Surfactant & Foaming Agents, 8 Rheology Modifiers, 7 API Stability Enhancers, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

98 News #PharmaBuzz

98 News #PharmaBuzz

GLOBAL SALES INFORMATION

18 US Medicaid Prescriptions, 266 Regulatory FDF Prices, 24 Annual Reports

MARKET PLACE

13 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

11 Health Canada Patents

11 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 9 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 20758 / DOSAGE - TABLET;ORAL - 12.5MG;300MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
hydrochlorothiazide(UNII: 0J48LPH2TH) (hydrochlorothiazide - UNII:0J48LPH2TH)	hydrochlorothiazide	12.5mg \| 12.5mg
irbesartan(UNII: J0E2756Z7N) (irbesartan - UNII:J0E2756Z7N)	irbesartan	300mg \| 150mg

Inactive Ingredients

Ingredient Name	Apotex Corp.	NuCare Pharmaceuticals, Inc.	REMEDYREPACK INC.	Cardinal Health	Legacy Pharmaceutical Packaging	Mylan Pharmaceuticals Inc.	AvKARE, Inc.	Proficient Rx LP	Qualitest Pharmaceuticals	Unichem Pharmaceuticals (USA), Inc.	Lupin Pharmaceuticals, Inc.	Rising Pharmaceuticals, Inc.
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(L11K75P92J)
CARBOXYMETHYLCELLULOSE CALCIUM(UTY7PDF93L)
carnauba wax(R12CBM0EIZ)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSCARMELLOSE SODIUM(M28OL1HH48)
CROSPOVIDONE(2S7830E561)
CROSPOVIDONE(68401960MK)
D&C YELLOW NO. 10(35SW5USQ3G)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
Hydroxypropyl Cellulose (Type H)(RFW2ET671P)
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
LECITHIN, SOYBEAN(1DI56QDM62)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLOXAMER 188(LQA7B6G8JG)
POLYETHYLENE GLYCOL 3000(SA1B764746)
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYETHYLENE GLYCOL 6000(30IQX730WE)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
POVIDONE K25(K0KQV10C35)
POVIDONE K29/32(390RMW2PEQ)
POVIDONE K30(U725QWY32X)
POVIDONE(FZ989GH94E)
POVIDONES(FZ989GH94E)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
SODIUM STEARYL FUMARATE(7CV7WJK4UI)
STARCH, CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Setid 716ab835 584e 4bdc Ac7c F685d88b4dad Applno 20758 Form Tablet Oral Dosage 12 5mg 300mg - Drug Product Composition: Aprovel

Aprovel

Aprovel

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

107 API Suppliers

41 USDMF

31 CEP/COS

17 JDMF

15 EU WC

27 KDMF

15 NDC API

45 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

10 Drugs in Development

INTERMEDIATES

18 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1014 FDF Dossiers

118 FDA Orange Book

629 Europe

63 Canada

50 Australia

34 South Africa

120 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 150MG

TABLET;ORAL - 300MG

TABLET;ORAL - 75MG

TABLET;ORAL - 12.5MG;150MG

TABLET;ORAL - 12.5MG;300MG

TABLET;ORAL - 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem

1 Rochem International Inc

18 SPI Pharma

6 DKSH

4 Boai NKY Pharmaceuticals Ltd

7 Gangwal Healthcare

10 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

1 Pfanstiehl

2 Kirsch Pharma

1 ACG Worldwide

5 Actylis

1 Aeon Procare

8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

1 Avesta Pharma

27 BASF

3 Clariant

10 Corel Pharma Chem

7 DFE Pharma

1 Esteem Industries

2 Finar

12 Gangwal Chemicals

5 Ideal Cures

5 Ingredion Pharma Solutions

26 Kerry

4 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

16 Microlex e.U

2 Nanjing Bold Chemical

3 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

3 Novo Excipients

4 Pharmatrans-Sanaq

7 Pluviaendo

5 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

20 Roquette

14 Seppic

8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

TABLET;ORAL - 12.5MG;75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 25MG;300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons