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- 50MG;50MG, CAPSULE;ORAL - 25MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 25MG;37.5MG, TABLET;ORAL - 50MG;75MG, TABLET;ORAL - 10MG;25MG, TABLET;ORAL - 5MG;12.5MG, TABLET;ORAL -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- 12.5MG;300MG, TABLET;ORAL - 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 12.5MG;160MG, TABLET;ORAL - 12.5MG;320MG, TABLET;ORAL - 12.5MG;80MG, TABLET;ORAL - 25MG;160MG,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EXTENDED RELEASE;ORAL - 12.5MG;EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 12.5MG;EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for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

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USFDA APPLICATION NUMBER - 20387 / DOSAGE - TABLET;ORAL - 25MG;100MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)	HYDROCHLOROTHIAZIDE	25mg
LOSARTAN POTASSIUM(UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89)	LOSARTAN POTASSIUM	100mg

Inactive Ingredients

Ingredient Name	Avera McKennan Hospital	AvKARE, Inc.	Bryant Ranch Prepack	Medsource Pharmaceuticals	Merck Sharp & Dohme Corp.	PD-Rx Pharmaceuticals, Inc.	REMEDYREPACK INC.	Watson Laboratories, Inc.	A-S Medication Solutions	Alembic Pharmaceuticals Inc.	AvPAK	Lake Erie Medical DBA Quality Care Products LLC	NorthStar RxLLC	Preferred Pharmaceuticals, Inc.	Sun Pharmaceutical Industries, Inc.	Torrent Pharmaceuticals Limited	Trigen Laboratories, LLC	Unit Dose Services	West-Ward Pharmaceuticals Corp.	GC Hanford Manufacturing Company	Apotex Corp.	Sandoz Inc.	ACETRIS HEALTH, LLC	American Health Packaging	Mylan Pharmaceuticals Inc.	NuCare Pharmaceuticals, Inc.	NuCare Pharmaceuticals,Inc.	Physicians Total Care, Inc.	Qualitest Pharmaceuticals	St Marys Medical Park Pharmacy	St. Marys Medical Park Pharmacy	Sandoz Inc	Direct Rx	McKesson Corporation dba SKY Packaging	NorthStar Rx LLC	Preferred Pharmaceuticals Inc.	Rising Health, LLC	Solco Healthcare US, LLC	ST. MARY'S MEDICAL PARK PHARMACY	Granules Pharmaceuticals Inc.
ALUMINUM OXIDE(LMI26O6933)
ANHYDROUS LACTOSE(3SY5LH9PMK)
ANHYDROUS TRISODIUM CITRATE(RS7A450LGA)
CARNAUBA WAX(R12CBM0EIZ)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
COLLOIDAL SILICON DIOXIDE(ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(M28OL1HH48)
D&C YELLOW NO. 10(35SW5USQ3G)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C RED NO. 40(WZB9127XOA)
FD&C YELLOW NO. 6 (H77VEI93A8)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE(RFW2ET671P)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(2165RE0K14)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
hypromellose(3NXW29V3WO)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)
LECITHIN, SOYBEAN(1DI56QDM62)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(2165RE0K14)
MAGNESIUM STEARATE(70097M6I30)
METHYLPARABEN(A2I8C7HI9T)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYDEXTROSE(VH2XOU12IE)
POLYETHYLENE GLYCOL 3000(SA1B764746)
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)
POLYETHYLENE GLYCOL 4000(4R4HFI6D95)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYVINYL ALCOHOL(532B59J990)
Polyvinyl Alcohol, Unspecified(532B59J990)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
PROPYLPARABEN(Z8IX2SC1OH)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM CHLORIDE(451W47IQ8X)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
STARCH, CORN(O8232NY3SJ)
STARCH, PREGELATINIZED CORN(O8232NY3SJ)
STEARIC ACID(4ELV7Z65AP)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)

Setid 7aad4b60 41ac 424f B1ae 5e7212b312e6 Applno 20387 Form Tablet Oral Dosage 25mg 100mg - Drug Product Composition: Aldactazide 25/25