Abacavir Sulfate

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ACTIVE PHARMA INGREDIENTS

30 API Suppliers, 12 USDMF, 10 CEP/COS, 1 JDMF, 11 EU WC, 3 KDMF, 14 NDC API, 15 Listed Suppliers, $ API Reference Price

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

66 FDF Dossiers, 34 FDA Orange Book, 8 Europe, 11 Canada, 10 South Africa, 3 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 600MG BASE;EQ 50MG BASE;300MG, TABLET;ORAL - EQ 300MG BASE, SOLUTION;ORAL - EQ 20MG BASE/ML, TABLET;ORAL - EQ 600MG BASE;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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66 Fillers, Diluents & Binders, 53 Coating Systems & Additives, 36 Direct Compression, 33 Controlled & Modified Release, 31 Disintegrants & Superdisintegrants, 24 Solubilizers, 24 Thickeners and Stabilizers, 21 Film Formers & Plasticizers, 20 Granulation, 20 Taste Masking, 18 Parenteral, 17 Co-Processed Excipients, 16 Chewable & Orodispersible Aids, 15 Topical, 14 Lubricants & Glidants, 8 Emulsifying Agents, 7 API Stability Enhancers, 5 Coloring Agents, 5 Rheology Modifiers, 5 Empty Capsules, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents, 1 Soft Gelatin

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GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 8 Finished Drug Prices, 5 Annual Reports

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PATENTS & EXCLUSIVITIES

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

REF. STANDARDS & IMPURITIES

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USFDA APPLICATION NUMBER - 20978 / DOSAGE - SOLUTION;ORAL - EQ 20MG BASE/ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ABACAVIR SULFATE(UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS)	ABACAVIR	20mg in 1

Inactive Ingredients

Ingredient Name	GlaxoSmithKline Inc
ANHYDROUS CITRIC ACID(XF417D3PSL)
METHYLPARABEN(A2I8C7HI9T)
PROPYLENE GLYCOL(6DC9Q167V3)
PROPYLPARABEN(Z8IX2SC1OH)
SACCHARIN SODIUM(SB8ZUX40TY)
SORBITOL(506T60A25R)
TRISODIUM CITRATE DIHYDRATE(B22547B95K)
WATER(059QF0KO0R)

Drug Product Composition: Abacavir Sulfate