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Generated: January 23, 2019

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Details for New Drug Application (NDA): 050680

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NDA 050680 describes CLEOCIN, which is a drug marketed by Pharmacia And Upjohn and is included in fourteen NDAs. It is available from three suppliers. There is one patent protecting this drug. Additional details are available on the CLEOCIN profile page.

The generic ingredient in CLEOCIN is clindamycin palmitate hydrochloride. There are fifty-five drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the clindamycin palmitate hydrochloride profile page.
Summary for 050680
Tradename:CLEOCIN
Applicant:Pharmacia And Upjohn
Ingredient:clindamycin phosphate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 050680
Suppliers and Packaging for NDA: 050680
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLEOCIN clindamycin phosphate CREAM;VAGINAL 050680 NDA Pharmacia and Upjohn Company LLC 0009-3448 0009-3448-01 1 TUBE, WITH APPLICATOR in 1 CARTON (0009-3448-01) > 40 g in 1 TUBE, WITH APPLICATOR
CLEOCIN clindamycin phosphate CREAM;VAGINAL 050680 NDA AUTHORIZED GENERIC Greenstone LLC 59762-5009 59762-5009-1 1 TUBE in 1 CARTON (59762-5009-1) > 40 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CREAM;VAGINALStrengthEQ 2% BASE
Approval Date:Aug 11, 1992TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CREAM;VAGINALStrengthEQ 2% BASE
Approval Date:Mar 2, 1998TE:ABRLD:Yes

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