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Levorphanol Tartrate

Levorphanol Tartrate Tablets USP, CII

Approved
Approval ID

438cf3ea-04fe-4626-9f0f-adcda7633651

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 29, 2021

Manufacturers
FDA

Sun Pharmaceutical Industries, Inc.

DUNS: 146974886

Products 1

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

Levorphanol Tartrate

PRODUCT DETAILS

NDC Product Code57664-762
Application NumberANDA213906
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 29, 2021
Generic NameLevorphanol Tartrate

INGREDIENTS (5)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LEVORPHANOL TARTRATEActive
Quantity: 2 mg in 1 1
Code: 04WQU6T9QI
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
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Levorphanol Tartrate - FDA Approval | MedPath