Clindamycin Phosphate

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ACTIVE PHARMA INGREDIENTS

35 API Suppliers, 19 USDMF, 12 CEP/COS, 6 JDMF, 1 EU WC, 1 KDMF, 13 NDC API, 18 Listed Suppliers, $ API Reference Price

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17 Drugs in Development

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1 Intermediates Suppliers

1 Intermediates Suppliers

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168 FDF Dossiers, 133 FDA Orange Book, 10 Europe, 15 Canada, 1 South Africa, 9 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;INTRAVENOUS - EQ 300MG BASE/50ML (EQ 6MG BASE/ML), SOLUTION;INTRAVENOUS - EQ 600MG BASE/50ML (EQ 12MG BASE/ML), SOLUTION;INTRAVENOUS - EQ 900MG BASE/50ML (EQ 18MG BASE/ML), INJECTABLE;INJECTION - EQ 150MG BASE/ML, SOLUTION;TOPICAL - EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, LOTION;TOPICAL - EQ 1% BASE, GEL;TOPICAL - EQ 1% BASE, GEL;TOPICAL - 5%;1.2%, GEL;TOPICAL - 5%;EQ 1% BASE, SUPPOSITORY;VAGINAL - 100MG, GEL;TOPICAL - EQ 1% BASE, CREAM;VAGINAL - EQ 2% BASE, AEROSOL, FOAM;TOPICAL - 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;TOPICAL - 1.2%;0.025%

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 3 SPI Pharma, 3 DKSH, 1 Pharm-RX Chemical, 2 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 8 Actylis, 1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 13 BASF, 1 BioSpectra, 1 Clariant, 6 Corel Pharma Chem, 2 Finar, 7 Gangwal Chemicals, 8 Kerry, 5 Lubrizol Life Science Health, 4 Microlex e.U, 1 Nanjing Bold Chemical, 2 Pluviaendo, 16 Roquette, 10 Seppic, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Sigachi Industries, 1 Valens Pharmachem, 1 Zhejiang Huakang Pharmaceutical

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4 US Medicaid Prescriptions, 9 Finished Drug Prices

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PATENTS & EXCLUSIVITIES

23 US Patents, 3 US Exclusivities

REF. STANDARDS & IMPURITIES

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USFDA APPLICATION NUMBER - 50803 / DOSAGE - GEL;TOPICAL - 1.2%;0.025%

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CLINDAMYCIN PHOSPHATE(UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C)	CLINDAMYCIN	10mg in 1
TRETINOIN(UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R)	TRETINOIN	0.25mg in 1

Inactive Ingredients

Ingredient Name	Actavis Pharma, Inc.	Stiefel Laboratories Inc
ANHYDROUS CITRIC ACID(XF417D3PSL)
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)(4Q93RCW27E)
EDETATE DISODIUM(7FLD91C86K)
GLYCERIN(PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)(R33S7TK2EP)
LAURETH-4(6HQ855798J)
METHYLPARABEN(A2I8C7HI9T)
POLYSORBATE 80(6OZP39ZG8H)
PROPYLENE GLYCOL(6DC9Q167V3)
PROPYLPARABEN(Z8IX2SC1OH)
TROMETHAMINE(023C2WHX2V)
WATER(059QF0KO0R)
XANTHAN GUM(TTV12P4NEE)

Drug Product Composition: Clindamycin Phosphate