Diphenhydramine HCl

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ACTIVE PHARMA INGREDIENTS

33 API Suppliers, 16 USDMF, 3 CEP/COS, 1 JDMF, 4 EU WC, 1 KDMF, 19 NDC API, 19 Listed Suppliers, $ API Reference Price

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1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

297 FDF Dossiers, 117 FDA Orange Book, 4 Europe, 94 Canada, 47 South Africa, 35 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT, INJECTABLE;INJECTION - 50MG/ML, ELIXIR;ORAL - 12.5MG/5ML

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GLOBAL SALES INFORMATION

5 Finished Drug Prices

5 Finished Drug Prices

MARKET PLACE

40 APIs, 3 FDF Dossiers

REF. STANDARDS & IMPURITIES

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USFDA APPLICATION NUMBER - 87513 / DOSAGE - ELIXIR;ORAL - 12.5MG/5ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Diphenhydramine Hydrochloride(UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M)	Diphenhydramine Hydrochloride	12.5mg in 5

Inactive Ingredients

Ingredient Name	Cardinal Health	Foxland Pharmaceuticals, Inc.
alcohol(3K9958V90M)
CITRIC ACID MONOHYDRATE(2968PHW8QP)
D&C RED NO. 33(9DBA0SBB0L)
FD&C Red No. 40(WZB9127XOA)
Sodium Citrate(1Q73Q2JULR)
SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR)
Sucrose(C151H8M554)
WATER(059QF0KO0R)

Drug Product Composition: Diphenhydramine HCl