clindamycin palmitate hydrochloride
Clindamycin Palmitate Hydrochloride for Oral Solution, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin palmitate hydrochloride for oral solution and other antibacterial drugs, clindamycin palmitate hydrochloride for oral solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Approved
Approval ID
d8cefc80-e0c7-4b18-83d6-5edd4f6f2af4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 26, 2020
Manufacturers
FDA
InvaGen Pharmaceuticals, Inc.
DUNS: 165104469
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 Code67787-515
Application NumberANDA206958
Product Classification
M
Marketing Category
C73584
G
Generic Name
clindamycin palmitate hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 27, 2020
FDA Product Classification
INGREDIENTS (8)
CHERRYInactive
Code: BUC5I9595W
Classification: IACT
ETHYLPARABENInactive
Code: 14255EXE39
Classification: IACT
CLINDAMYCIN PALMITATE HYDROCHLORIDEActive
Quantity: 75 mg in 5 mL
Code: VN9A8JM7M7
Classification: ACTIM
ICODEXTRINInactive
Code: 2NX48Z0A9G
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT