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clindamycin hydrochloride

Approved
Approval ID

63a0466c-af7d-4696-a950-19b73b55a65a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 24, 2011

Manufacturers
FDA

RedPharm Drug Inc.

DUNS: 008039641

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 Code67296-0315
Application NumberANDA065442
Product Classification
M
Marketing Category
C73584
G
Generic Name
clindamycin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 24, 2011
FDA Product Classification

INGREDIENTS (10)

CLINDAMYCIN HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: T20OQ1YN1W
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT

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clindamycin hydrochloride - FDA Drug Approval Details