Clindacin P
Clindacin•P Clindamycin Phosphate Topical Solution USP, 1% (Pledgets)
Approved
Approval ID
288371ef-96b6-4ce3-9be1-1d9d309b400c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 15, 2023
Manufacturers
FDA
Medimetriks Pharmaceuticals, Inc.
DUNS: 019903816
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
clindamycin phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43538-170
Application NumberANDA065049
Product Classification
M
Marketing Category
C73584
G
Generic Name
clindamycin phosphate
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 15, 2023
FDA Product Classification
INGREDIENTS (5)
isopropyl alcoholInactive
Code: ND2M416302
Classification: IACT
clindamycin phosphateActive
Quantity: 10 mg in 1 mL
Code: EH6D7113I8
Classification: ACTIM
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
clindamycin phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43538-171
Application NumberANDA065049
Product Classification
M
Marketing Category
C73584
G
Generic Name
clindamycin phosphate
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 15, 2023
FDA Product Classification
INGREDIENTS (5)
clindamycin phosphateActive
Quantity: 10 mg in 1 1
Code: EH6D7113I8
Classification: ACTIM
isopropyl alcoholInactive
Code: ND2M416302
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT