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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 216662

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NDA 216662 describes LINCOMYCIN HYDROCHLORIDE, which is a drug marketed by Arthur Grp, Gland, Micro Labs, Slate Run Pharma, Slayback, and Xgen Pharms, and is included in six NDAs. It is available from eight suppliers. Additional details are available on the LINCOMYCIN HYDROCHLORIDE profile page.

The generic ingredient in LINCOMYCIN HYDROCHLORIDE is lincomycin hydrochloride. There are eleven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the lincomycin hydrochloride profile page.

Summary for 216662

Tradename:	LINCOMYCIN HYDROCHLORIDE
Applicant:	Slate Run Pharma
Ingredient:	lincomycin hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 216662

Anti-Bacterial Agents
Protein Synthesis Inhibitors

Suppliers and Packaging for NDA: 216662

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LINCOMYCIN HYDROCHLORIDE	lincomycin hydrochloride	INJECTABLE;INJECTION	216662	ANDA	Slate Run Pharmaceuticals, LLC	70436-034	70436-034-82	10 VIAL in 1 CARTON (70436-034-82) / 2 mL in 1 VIAL
LINCOMYCIN HYDROCHLORIDE	lincomycin hydrochloride	INJECTABLE;INJECTION	216662	ANDA	Slate Run Pharmaceuticals, LLC	70436-035	70436-035-80	1 VIAL in 1 CARTON (70436-035-80) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 300MG BASE/ML
Approval Date:	Dec 21, 2022	TE:		RLD:	No

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