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Generated: March 23, 2019

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Details for New Drug Application (NDA): 050767

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NDA 050767 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 050767
Tradename:CLEOCIN
Applicant:Pharmacia And Upjohn
Ingredient:clindamycin phosphate
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 050767
Suppliers and Packaging for NDA: 050767
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLEOCIN clindamycin phosphate SUPPOSITORY;VAGINAL 050767 NDA Pharmacia and Upjohn Company LLC 0009-7667 0009-7667-01 1 BLISTER PACK in 1 CARTON (0009-7667-01) > 3 SUPPOSITORY in 1 BLISTER PACK
CLEOCIN clindamycin phosphate SUPPOSITORY;VAGINAL 050767 NDA U.S. Pharmaceuticals 63539-011 63539-011-01 1 BLISTER PACK in 1 CARTON (63539-011-01) > 3 SUPPOSITORY in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUPPOSITORY;VAGINALStrength100MG
Approval Date:Aug 13, 1999TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jul 20, 2020Product Flag?YSubstance Flag?Delist Request?

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