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Generated: November 20, 2018

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Details for New Drug Application (NDA): 208083

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NDA 208083 describes CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE, which is a drug marketed by Baxter Hlthcare Corp and is included in one NDA. It is available from one supplier. Additional details are available on the CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE profile page.

The generic ingredient in CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE is clindamycin phosphate. There are fifty-five drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.
Summary for 208083
Tradename:CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE
Applicant:Baxter Hlthcare Corp
Ingredient:clindamycin phosphate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 208083
Ingredient-typeLincosamides
Physiological EffectDecreased Sebaceous Gland Activity
Suppliers and Packaging for NDA: 208083
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE clindamycin phosphate SOLUTION;IV (INFUSION) 208083 NDA Baxter Healthcare Corporation 0338-9545 0338-9545-24 24 BAG in 1 CARTON (0338-9545-24) > 50 mL in 1 BAG (0338-9545-50)
CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE clindamycin phosphate SOLUTION;IV (INFUSION) 208083 NDA Baxter Healthcare Corporation 0338-9549 0338-9549-24 24 BAG in 1 CARTON (0338-9549-24) > 50 mL in 1 BAG (0338-9549-50)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)StrengthEQ 300MG BASE/50ML (EQ 6MG BASE/ML)
Approval Date:Apr 20, 2017TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)StrengthEQ 600MG BASE/50ML (EQ 12MG BASE/ML)
Approval Date:Apr 20, 2017TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)StrengthEQ 900MG BASE/50ML (EQ 18MG BASE/ML)
Approval Date:Apr 20, 2017TE:RLD:Yes

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