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CLINDAMYCIN HYDROCHLORIDE

CLINDAMYCIN HYDROCHLORIDE 150mg

Approved
Approval ID

2ebc6f29-d014-4c86-e054-00144ff8d46c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 20, 2020

Manufacturers
FDA

DIRECT RX

DUNS: 079254320

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 Code61919-057
Application NumberANDA065061
Product Classification
M
Marketing Category
C73584
G
Generic Name
CLINDAMYCIN HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2020
FDA Product Classification

INGREDIENTS (12)

SHELLACInactive
Code: 46N107B71O
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CLINDAMYCIN HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: T20OQ1YN1W
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT

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CLINDAMYCIN HYDROCHLORIDE - FDA Drug Approval Details