An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 216152
Company: SOMERSET

Products on ANDA 216152

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZINC CHLORIDE	ZINC CHLORIDE	EQ 1MG ZINC/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216152

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/16/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216152

ZINC CHLORIDE

INJECTABLE;INJECTION; EQ 1MG ZINC/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ZINC CHLORIDE	ZINC CHLORIDE	EQ 1MG ZINC/ML	INJECTABLE;INJECTION	Prescription	No	AP	212007	EXELA PHARMA
ZINC CHLORIDE	ZINC CHLORIDE	EQ 1MG ZINC/ML	INJECTABLE;INJECTION	Prescription	No	AP	217625	RK PHARMA
ZINC CHLORIDE	ZINC CHLORIDE	EQ 1MG ZINC/ML	INJECTABLE;INJECTION	Prescription	No	AP	216152	SOMERSET
ZINC CHLORIDE IN PLASTIC CONTAINER	ZINC CHLORIDE	EQ 1MG ZINC/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018959	HOSPIRA

Top