METHYLDOPA AND HYDROCHLOROTHIAZIDE

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

60 API Suppliers, 31 USDMF, 24 CEP/COS, 7 JDMF, 10 EU WC, 17 KDMF, 19 NDC API, 28 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

4 Intermediates Suppliers

4 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

3607 FDF Dossiers, 878 FDA Orange Book, 1902 Europe, 229 Canada, 2 Australia, 202 South Africa, 394 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- 50MG;50MG, CAPSULE;ORAL - 25MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 25MG;37.5MG, TABLET;ORAL - 50MG;75MG, TABLET;ORAL - 10MG;25MG, TABLET;ORAL - 5MG;12.5MG, TABLET;ORAL -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- 12.5MG;300MG, TABLET;ORAL - 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 12.5MG;160MG, TABLET;ORAL - 12.5MG;320MG, TABLET;ORAL - 12.5MG;80MG, TABLET;ORAL - 25MG;160MG, TABLET;ORAL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EXTENDED RELEASE;ORAL - 12.5MG;EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 12.5MG;EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for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 - 25MG, TABLET;ORAL - 50MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Evonik, 3 Rochem International Inc, 25 SPI Pharma, 2 Seqens, 17 DKSH, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 10 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 15 Gangwal Healthcare, 14 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 10 Actylis, 1 Aeon Procare, 4 Alcedo Pharmachem, 11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 39 BASF, 3 Clariant, 13 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 3 Finar, 13 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 20 Microlex e.U, 2 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 5 Novo Excipients, 5 Pharmatrans-Sanaq, 8 Pluviaendo, 6 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, 12 Sigachi Industries, 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

119 Fillers, Diluents & Binders, 62 Coating Systems & Additives, 59 Direct Compression, 50 Disintegrants & Superdisintegrants, 40 Granulation, 40 Solubilizers, 40 Thickeners and Stabilizers, 38 Controlled & Modified Release, 38 Lubricants & Glidants, 36 Film Formers & Plasticizers, 33 Topical, 31 Parenteral, 28 Taste Masking, 24 Co-Processed Excipients, 21 Chewable & Orodispersible Aids, 14 Emulsifying Agents, 10 API Stability Enhancers, 9 Empty Capsules, 8 Surfactant & Foaming Agents, 7 Rheology Modifiers, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 145 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

8 US Medicaid Prescriptions, 1837 Finished Drug Prices, 16 Annual Reports

MARKET PLACE

30 APIs, 18 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 US Patents

4 US Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 3 JP, 3 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 19888 / DOSAGE - TABLET;ORAL - 25MG;20MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)	HYDROCHLOROTHIAZIDE	25mg \| 12.5mg \| 12.5mg
LISINOPRIL(UNII: E7199S1YWR) (LISINOPRIL ANHYDROUS - UNII:7Q3P4BS2FD)	LISINOPRIL	20mg \| 20mg \| 10mg

Inactive Ingredients

Ingredient Name	American Health Packaging	AvPAK	Bryant Ranch Prepack	Clinical Solutions Wholesale	IVAX Pharmaceuticals, Inc.	NCS HealthCare of KY, Inc dba Vangard Labs	PD-Rx Pharmaceuticals, Inc.	Preferred Pharmaceuticals, Inc.	Unit Dose Services	A-S Medication Solutions	AvKARE, Inc.	Citron Pharma LLC	Eon Labs, Inc.	Hikma Pharmaceuticals USA Inc.	Lake Erie medical DBA Quality Care Products LLC	Legacy Pharmaceutical Packaging, LLC	NuCare Pharmaceuticals, Inc.	Preferred Pharmaceuticals Inc.	REMEDYREPACK INC.	St Marys Medical Park Pharmacy	Apotex Corp.	Aphena Pharma Solutions - Tennessee, LLC	Golden State Medical Supply, Inc.	International Laboratories, LLC	AstraZeneca Pharmaceuticals LP	Mylan Pharmaceuticals Inc.	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	Direct_Rx	Quality Care Products, LLC	REMEDYREPACK INC.
ALUMINUM OXIDE(LMI26O6933)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)
ANHYDROUS LACTOSE(3SY5LH9PMK)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(L11K75P92J)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(O7TSZ97GEP)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSCARMELLOSE SODIUM(M28OL1HH48)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
CROSPOVIDONE(68401960MK)
D&C YELLOW NO. 10(35SW5USQ3G)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(O7TSZ97GEP)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C RED NO. 40(WZB9127XOA)
FD&C YELLOW NO. 6(H77VEI93A8)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POVIDONE, UNSPECIFIED(FZ989GH94E)
POVIDONES(FZ989GH94E)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
STARCH, CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)
WATER(059QF0KO0R)

Drug Product Composition: METHYLDOPA AND HYDROCHLOROTHIAZIDE