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Clindamycin Hydrochloride

Clindamycin Hydrochloride Capsules USP150 mg and 300 mgRx only

Approved
Approval ID

9891d1bd-b662-4242-a01e-8151463bbf2d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 27, 2010

Manufacturers
FDA

Contract Pharmacy Services-PA

DUNS: 945429777

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Clindamycin Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67046-085
Application NumberANDA065194
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clindamycin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 3, 2009
FDA Product Classification

INGREDIENTS (8)

D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
CLINDAMYCIN HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: T20OQ1YN1W
Classification: ACTIR
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT

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Clindamycin Hydrochloride - FDA Drug Approval Details