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lincomycin

Lincomycin Injection, USP

Approved
Approval ID

7efe038a-8d67-4151-864a-b4863b46643e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 24, 2023

Manufacturers
FDA

Slate Run Pharmaceuticals, LLC

DUNS: 039452765

Products 2

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

lincomycin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70436-035
Application NumberANDA216662
Product Classification
M
Marketing Category
C73584
G
Generic Name
lincomycin
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateJanuary 24, 2023
FDA Product Classification

INGREDIENTS (2)

LINCOMYCINActive
Quantity: 300 mg in 1 mL
Code: BOD072YW0F
Classification: ACTIB
BENZYL ALCOHOLInactive
Quantity: 9.45 mg in 1 mL
Code: LKG8494WBH
Classification: IACT

lincomycin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70436-034
Application NumberANDA216662
Product Classification
M
Marketing Category
C73584
G
Generic Name
lincomycin
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateJanuary 24, 2023
FDA Product Classification

INGREDIENTS (2)

BENZYL ALCOHOLInactive
Quantity: 9.45 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
LINCOMYCINActive
Quantity: 300 mg in 1 mL
Code: BOD072YW0F
Classification: ACTIB

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lincomycin - FDA Drug Approval Details