Last Updated: November 8, 2026

Details for New Drug Application (NDA): 212770

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NDA 212770 describes LINCOMYCIN HYDROCHLORIDE, which is a drug marketed by Gland, Hainan Poly, Micro Labs, Quagen, 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 is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the lincomycin hydrochloride profile page.

Summary for 212770

Tradename:	LINCOMYCIN HYDROCHLORIDE
Applicant:	Quagen
Ingredient:	lincomycin hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 212770

Anti-Bacterial Agents
Protein Synthesis Inhibitors

Suppliers and Packaging for NDA: 212770

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LINCOMYCIN HYDROCHLORIDE	lincomycin hydrochloride	INJECTABLE;INJECTION	212770	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-1035	0121-1035-55	10 VIAL, MULTI-DOSE in 1 CARTON (0121-1035-55) / 10 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 300MG BASE/ML
Approval Date:	Mar 12, 2021	TE:	AP	RLD:	No

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