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- 50MG;50MG, CAPSULE;ORAL - 25MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 25MG;37.5MG, TABLET;ORAL - 50MG;75MG, TABLET;ORAL - 10MG;25MG, TABLET;ORAL - 5MG;12.5MG, TABLET;ORAL -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- 12.5MG;300MG, TABLET;ORAL - 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 12.5MG;160MG, TABLET;ORAL - 12.5MG;320MG, TABLET;ORAL - 12.5MG;80MG, TABLET;ORAL - 25MG;160MG, TABLET;ORAL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EXTENDED RELEASE;ORAL - 12.5MG;EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 12.5MG;EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for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 - 12616 / DOSAGE - TABLET;ORAL - 25MG;25MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
hydrochlorothiazide(UNII: 0J48LPH2TH) (hydrochlorothiazide - UNII:0J48LPH2TH)	hydrochlorothiazide	25mg
spironolactone(UNII: 27O7W4T232) (spironolactone - UNII:27O7W4T232)	spironolactone	25mg

Inactive Ingredients

Ingredient Name	American Health Packaging	Mylan Pharmaceuticals Inc.	A-S Medication Solutions LLC	Pfizer Laboratories Div Pfizer Inc	Mylan Institutional Inc.
ANHYDROUS LACTOSE(3SY5LH9PMK)
calcium sulfate(WAT0DDB505)
CALCIUM SULFATE, UNSPECIFIED FORM(WAT0DDB505)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSCARMELLOSE SODIUM(M28OL1HH48)
D&C YELLOW NO. 10(35SW5USQ3G)
DOCUSATE SODIUM(F05Q2T2JA0)
FD&C YELLOW NO. 6(H77VEI93A8)
ferric oxide red(1K09F3G675)
hydroxypropyl cellulose(RFW2ET671P)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
hypromelloses(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
magnesium stearate(70097M6I30)
MENTHOL, UNSPECIFIED FORM(L7T10EIP3A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
PEPPERMINT OIL(AV092KU4JH)
PEPPERMINT(V95R5KMY2B)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
polyethylene glycols(3WJQ0SDW1A)
povidone(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
POVIDONES(FZ989GH94E)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM BENZOATE(OJ245FE5EU)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
STARCH, CORN(O8232NY3SJ)
TITANIUM DIOXIDE(15FIX9V2JP)

Setid Bd8779c8 Fcb4 4f01 Bd0a 20152d46a085 Applno 12616 Form Tablet Oral Dosage 25mg 25mg - Drug Product Composition: Aldactazide 25/25