Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216324
Company: AM REGENT

Products on ANDA 216324

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CUPRIC SULFATE	CUPRIC SULFATE	EQ 0.4MG COPPER/ML	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216324

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/16/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216324Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/27/2024	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 216324

CUPRIC SULFATE

INJECTABLE;INJECTION; EQ 0.4MG COPPER/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CUPRIC SULFATE	CUPRIC SULFATE	EQ 0.4MG COPPER/ML	INJECTABLE;INJECTION	Prescription	No	AP	216324	AM REGENT
CUPRIC SULFATE	CUPRIC SULFATE	EQ 0.4MG COPPER/ML	INJECTABLE;INJECTION	Prescription	No	AP	218745	APOTEX CORP