clindamycin palmitate hydrochloride
Clindamycin palmitate hydrochloride for oral solution, USP For pediatric use
Approved
Approval ID
e17229b3-7246-4886-abe6-58e39c4e47ef
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2023
Manufacturers
FDA
Greenstone LLC
DUNS: 825560733
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 Code59762-0016
Application NumberANDA062644
Product Classification
M
Marketing Category
C73584
G
Generic Name
clindamycin palmitate hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 17, 2023
FDA Product Classification
INGREDIENTS (5)
CLINDAMYCIN PALMITATE HYDROCHLORIDEActive
Quantity: 75 mg in 5 mL
Code: VN9A8JM7M7
Classification: ACTIM
ETHYLPARABENInactive
Code: 14255EXE39
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT