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Clindamycin Hydrochloride

Approved
Approval ID

3fc64a22-9db7-2117-e054-00144ff88e88

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 1, 2009

Manufacturers
FDA

RedPharm Drug, Inc.

DUNS: 828374897

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 Code67296-0073
Application NumberANDA063083
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clindamycin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2009
FDA Product Classification

INGREDIENTS (12)

FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
CLINDAMYCIN HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: T20OQ1YN1W
Classification: ACTIM
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT

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Clindamycin Hydrochloride - FDA Drug Approval Details