clindamycin and benzoyl peroxide
Clindamycin and Benzoyl Peroxide Topical Gel, 1%/5%
Approved
Approval ID
e19de12c-f29b-42ab-9e81-1af8e4a66643
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 28, 2019
Manufacturers
FDA
NorthStar RxLLC
DUNS: 830546433
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
clindamycin and benzoyl peroxide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-984
Application NumberANDA209252
Product Classification
M
Marketing Category
C73584
G
Generic Name
clindamycin and benzoyl peroxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 28, 2019
FDA Product Classification
INGREDIENTS (7)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CLINDAMYCIN PHOSPHATEActive
Quantity: 10 mg in 1 g
Code: EH6D7113I8
Classification: ACTIB
BENZOYL PEROXIDEActive
Quantity: 50 mg in 1 g
Code: W9WZN9A0GM
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT