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ETRAVIRINE

These highlights do not include all the information needed to use ETRAVIRINE TABLETS safely and effectively.See full prescribing information for ETRAVIRINE TABLETS. ETRAVIRINE tablets, for oral useInitial U.S. Approval: 2008

Approved
Approval ID

48ffeac8-38e8-4007-903a-dbffce25d679

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 10, 2024

Manufacturers
FDA

Leading Pharma, LLC

DUNS: 079575060

Products 2

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

ETRAVIRINE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69315-285
Application NumberANDA215402
Product Classification
M
Marketing Category
C73584
G
Generic Name
ETRAVIRINE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2024
FDA Product Classification

INGREDIENTS (8)

MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
PovidoneInactive
Code: FZ989GH94E
Classification: IACT
ETRAVIRINEActive
Quantity: 100 mg in 1 1
Code: 0C50HW4FO1
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT

ETRAVIRINE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69315-286
Application NumberANDA215402
Product Classification
M
Marketing Category
C73584
G
Generic Name
ETRAVIRINE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2024
FDA Product Classification

INGREDIENTS (8)

ETRAVIRINEActive
Quantity: 200 mg in 1 1
Code: 0C50HW4FO1
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
PovidoneInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

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ETRAVIRINE - FDA Drug Approval Details