Aldactazide 25/25

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

80 API Suppliers, 32 USDMF, 24 CEP/COS, 7 JDMF, 9 EU WC, 17 KDMF, 17 NDC API, 34 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

14 Drugs in Development

14 Drugs in Development

INTERMEDIATES

6 Intermediate Suppliers

6 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

4469 FDF Dossiers, 907 FDA Orange Book, 2702 Europe, 230 Canada, 2 Australia, 217 South Africa, 411 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 25MG;25MG, TABLET;ORAL - 50MG;50MG, CAPSULE;ORAL - 25MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 25MG;37.5MG, TABLET;ORAL - 50MG;75MG, TABLET;ORAL - 10MG;25MG, TABLET;ORAL - 5MG;12.5MG, TABLET;ORAL - 12.5MG;10MG, TABLET;ORAL - 12.5MG;20MG, TABLET;ORAL - 25MG;20MG, TABLET;ORAL - 12.5MG;100MG, TABLET;ORAL - 12.5MG;50MG, TABLET;ORAL - 25MG;100MG, CAPSULE;ORAL - 12.5MG, 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- 12.5MG;300MG, TABLET;ORAL - 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 12.5MG;160MG, TABLET;ORAL - 12.5MG;320MG, TABLET;ORAL - 12.5MG;80MG, TABLET;ORAL - 25MG;160MG, TABLET;ORAL - 25MG;320MG, TABLET;ORAL - 16MG;12.5MG, TABLET;ORAL - 32MG;12.5MG, TABLET;ORAL - 32MG;25MG, TABLET;ORAL - 12.5MG;40MG, TABLET;ORAL - 12.5MG;80MG, TABLET;ORAL - 25MG;80MG, TABLET;ORAL - 12.5MG;20MG, TABLET;ORAL - 12.5MG;40MG, TABLET;ORAL - 25MG;40MG, TABLET, EXTENDED RELEASE;ORAL - 12.5MG;EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 12.5MG;EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE;12.5MG;160MG, TABLET;ORAL - EQ 10MG BASE;25MG;160MG, TABLET;ORAL - EQ 10MG BASE;25MG;320MG, TABLET;ORAL - EQ 5MG BASE;12.5MG;160MG, TABLET;ORAL - EQ 5MG BASE;25MG;160MG, TABLET;ORAL - 12.5MG, TABLET;ORAL - 25MG, TABLET;ORAL - 50MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Minakem, 1 Evonik, 3 Rochem International Inc, 26 SPI Pharma, 21 DKSH, 1 Pharm-RX Chemical, 10 Boai NKY Pharmaceuticals Ltd, 8 Gangwal Healthcare, 14 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 8 Kirsch Pharma, 4 ACG Worldwide, 10 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 Ashland, 1 Avesta Pharma, 39 BASF, 4 CD Formulation, 3 Clariant, 13 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 1 Esteem Industries, 3 Finar, 13 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 5 Ingredion Pharma Solutions, 26 Kerry, 4 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 20 Microlex e.U, 2 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 5 Novo Excipients, 5 Pharmatrans-Sanaq, 8 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 29 Roquette, 16 Seppic, 9 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 5 Silverline Chemicals, 1 Symrise, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 2 Valens Pharmachem, 6 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

102 Fillers, Diluents & Binders, 56 Coating Systems & Additives, 53 Direct Compression, 52 Disintegrants & Superdisintegrants, 47 Thickeners and Stabilizers, 45 Granulation, 42 Solubilizers, 38 Topical, 37 Lubricants & Glidants, 35 Parenteral, 34 Film Formers & Plasticizers, 33 Controlled & Modified Release, 30 Taste Masking, 23 Chewable & Orodispersible Aids, 17 Co-Processed Excipients, 15 Emulsifying Agents, 12 Rheology Modifiers, 11 Surfactant & Foaming Agents, 9 Empty Capsules, 9 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

150 News #PharmaBuzz

150 News #PharmaBuzz

GLOBAL SALES INFORMATION

127 US Medicaid Prescriptions, 917 Regulatory FDF Prices, 37 Annual Reports

MARKET PLACE

34 APIs, 18 FDF Dossiers

PATENTS & EXCLUSIVITIES

6 US Patents, 68 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 2 USP, 3 JP, 7 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: Aldactazide 25/25