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Details for New Drug Application (NDA): 050639

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NDA 050639 describes CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Pharmacia And Upjohn and is included in one NDA. It is available from one supplier. Additional details are available on the CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER profile page.

The generic ingredient in CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER is clindamycin phosphate. There are fifty-two drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.

Summary for NDA: 050639

Tradename:
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Applicant:
Pharmacia And Upjohn
Ingredient:
clindamycin phosphate
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 050639

Ingredient-typeLincosamides
Physiological EffectDecreased Sebaceous Gland Activity

Suppliers and Packaging for NDA: 050639

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
clindamycin phosphate
INJECTABLE;INJECTION 050639 NDA Pharmacia and Upjohn Company LLC 0009-3375 0009-3375-02 2 CARTON in 1 PACKAGE (0009-3375-02) > 12 BAG in 1 CARTON > 50 mL in 1 BAG (0009-3375-01)
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
clindamycin phosphate
INJECTABLE;INJECTION 050639 NDA Pharmacia and Upjohn Company LLC 0009-3381 0009-3381-02 2 CARTON in 1 PACKAGE (0009-3381-02) > 12 BAG in 1 CARTON > 50 mL in 1 BAG (0009-3381-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 6MG BASE/ML
Approval Date:Aug 30, 1989TE:APRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 12MG BASE/ML
Approval Date:Aug 30, 1989TE:APRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 18MG BASE/ML
Approval Date:Apr 10, 1991TE:APRLD:Yes


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