Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215657
Company: GLAND PHARMA LTD

Products on ANDA 215657

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LINCOMYCIN HYDROCHLORIDE	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215657

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/26/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 215657

LINCOMYCIN HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 300MG BASE/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LINCOCIN	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	050317	PFIZER
LINCOMYCIN HYDROCHLORIDE	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	215657	GLAND PHARMA LTD
LINCOMYCIN HYDROCHLORIDE	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	215082	MICRO LABS
LINCOMYCIN HYDROCHLORIDE	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	201746	XGEN PHARMS