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CLINDAMYCIN PHOSPHATE

Approved
Approval ID

b6bb039f-5f5e-4aa7-bc70-5fb95935e2b0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 1, 2011

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 phosphate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-4805
Application NumberANDA065049
Product Classification
M
Marketing Category
C73584
G
Generic Name
clindamycin phosphate
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 1, 2011
FDA Product Classification

INGREDIENTS (5)

PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CLINDAMYCIN PHOSPHATEActive
Quantity: 10 mg in 1 mL
Code: EH6D7113I8
Classification: ACTIM
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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CLINDAMYCIN PHOSPHATE - FDA Drug Approval Details