EPI
ozenoxacin cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43538-320
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
ozenoxacin (UNII: V0LH498RFO) (ozenoxacin - UNII:V0LH498RFO) ozenoxacin 10 mg in 1 g
Inactive Ingredients
Ingredient Name
Strength
Benzoic Acid (UNII: 8SKN0B0MIM)
Apricot Kernel Oil Peg-6 Esters (UNII: DRG3KJZ1TJ)
Pegoxol 7 Stearate (UNII: 3EW5AXE5X5)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
#
Item Code
Package Description
Marketing Start Date
Marketing End Date
1NDC:43538-320-99 4 in 1 BOX 12/15/2017
1 3 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:43538-320-10 1 in 1 BOX 12/15/2017
2 10 g in 1 TUBE; Type 0: Not a Combination Product
3 NDC:43538-320-30 1 in 1 BOX 12/15/2017
3 30 g in 1 TUBE; Type 0: Not a Combination Product
4 NDC:43538-320-45 1 in 1 BOX 12/15/2017
4 45 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
NDA NDA208945 12/15/2017
Labeler - Medimetriks Pharmaceuticals, Inc. (019903816)
Establishment
Name
Address
ID/FEI
Business Operations
Teligent Pharma,Inc. 011036910 MANUFACTURE(43538-320) , PACK(43538-320)
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=562a0ba0-c9e4-4885-9050-903997cdfe6f
