Cleocin
Cleocin Pediatric (clindamycin palmitate hydrochloride for oral solution, USP)
Approved
Approval ID
b225ab20-bc7c-43af-ae93-0f07d5948e1c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 23, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
clindamycin palmitate hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5833
Application NumberANDA061772
Product Classification
M
Marketing Category
C73584
G
Generic Name
clindamycin palmitate hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2010
FDA Product Classification
INGREDIENTS (3)
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ETHYLPARABENInactive
Code: 14255EXE39
Classification: IACT
CLINDAMYCIN PALMITATE HYDROCHLORIDEActive
Quantity: 75 mg in 5 mL
Code: VN9A8JM7M7
Classification: ACTIB