(.+-.)-p-Isobutylhydratropic acid | 21394 | TABLET;ORAL | 38MG;200MG

(+-)-p-Isobutylhydratropic acid

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ACTIVE PHARMA INGREDIENTS

94 API Suppliers, 60 USDMF, 13 CEP/COS, 4 JDMF, 6 EU WC, 91 KDMF, 37 NDC API, 36 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

28 Drugs in Development

28 Drugs in Development

INTERMEDIATES

3 Intermediates Suppliers

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

1118 FDF Dossiers, 318 FDA Orange Book, 332 Europe, 82 Canada, 15 Australia, 116 South Africa, 255 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 200MG, TABLET;ORAL - 200MG, TABLET;ORAL - 200MG;30MG, CAPSULE;ORAL - EQ 200MG FREE ACID AND POTASSIUM SALT, SUSPENSION;ORAL - 100MG/5ML, CAPSULE;ORAL - EQ 200MG FREE ACID AND POTASSIUM SALT;30MG, CAPSULE;ORAL - 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT, TABLET;ORAL - 38MG;200MG, TABLET;ORAL - 2MG;200MG;30MG, TABLET;ORAL - 4MG;200MG;10MG, TABLET;ORAL - 200MG;10MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 10 Rochem International Inc, 20 SPI Pharma, 2 Seqens, 19 DKSH, 2 Jai Radhe Sales, 3 Pharm-RX Chemical, 10 Faran Shimi Pharmaceutical, 12 Boai NKY Pharmaceuticals Ltd, 16 Gangwal Healthcare, 2 Kewpie Corporation, 15 Nanjing Well Pharmaceutical, 3 Pfanstiehl, 4 ACG Worldwide, 12 Actylis, 3 Aeon Procare, 3 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 37 BASF, 1 Bioplus Life Sciences, 6 Clariant, 12 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 14 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 24 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nomisma Healthcare, 5 Novo Excipients, 4 Pharmatrans-Sanaq, 11 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 41 Roquette, 16 Seppic, 8 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, 4 Ulanqab Kema New Material, 1 Valens Pharmachem, 5 Vasa Pharmachem, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

131 Fillers, Diluents & Binders, 63 Coating Systems & Additives, 58 Direct Compression, 50 Thickeners and Stabilizers, 44 Disintegrants & Superdisintegrants, 43 Solubilizers, 38 Controlled & Modified Release, 35 Parenteral, 35 Granulation, 34 Film Formers & Plasticizers, 34 Topical, 33 Taste Masking, 31 Lubricants & Glidants, 23 Co-Processed Excipients, 22 Chewable & Orodispersible Aids, 20 Emulsifying Agents, 13 API Stability Enhancers, 12 Rheology Modifiers, 9 Empty Capsules, 8 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

7 DATA COMPILATION #PharmaFlow, 173 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 262 Finished Drug Prices

MARKET PLACE

88 APIs, 38 FDF Dossiers

PATENTS & EXCLUSIVITIES

26 US Patents, 8 US Exclusivities, 4 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 2 USP, 27 Others

ANALYTICAL

2 BioAnalytical Methods, 1 Analytical Methods

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USFDA APPLICATION NUMBER - 21394 / DOSAGE - TABLET;ORAL - 38MG;200MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE CITRATE(UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE CITRATE	38mg
IBUPROFEN(UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200mg

Inactive Ingredients

Ingredient Name	Haleon US Holdings LLC	WYETH CONSUMER HEALTHCARE LLC	7-Eleven	Amerisource Bergen	Cardinal Health	CVS Pharmacy	DZA Brands LLC	HyVee Inc	Supervalu Inc	Wakefern Food Corporation	Walgreen Company	Dolgencorp Inc	H E B	Kmart Corporation	Shopko Stores Operating Co., LLC
CALCIUM STEARATE(776XM7047L)
CARNAUBA WAX(R12CBM0EIZ)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSCARMELLOSE SODIUM(M28OL1HH48)
FD&C BLUE NO. 2(L06K8R7DQK)
FERROSOFERRIC OXIDE(XM0M87F357)
GLYCERYL DIBEHENATE(R8WTH25YS2)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE(RFW2ET671P)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYDEXTROSE(VH2XOU12IE)
POLYETHYLENE GLYCOL(3WJQ0SDW1A)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYVINYL ALCOHOL(532B59J990)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
STARCH, CORN(O8232NY3SJ)
STEARIC ACID(4ELV7Z65AP)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: (.+-.)-p-Isobutylhydratropic acid