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): 210892
Company: GLAND PHARMA LTD

Products on ANDA 210892

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVOLEUCOVORIN CALCIUM	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No
LEVOLEUCOVORIN CALCIUM	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210892

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/14/2018	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210892Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/12/2023	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
07/12/2023	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210892

LEVOLEUCOVORIN CALCIUM

SOLUTION;INTRAVENOUS; EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEVOLEUCOVORIN CALCIUM	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	207548	AMNEAL
LEVOLEUCOVORIN CALCIUM	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	210892	GLAND PHARMA LTD
LEVOLEUCOVORIN CALCIUM	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217314	HAINAN POLY PHARM
LEVOLEUCOVORIN CALCIUM	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	211002	MEITHEAL
LEVOLEUCOVORIN CALCIUM	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	203563	SANDOZ

SOLUTION;INTRAVENOUS; EQ 250MG BASE/25ML (EQ 10MG BASE/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEVOLEUCOVORIN CALCIUM	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	210892	GLAND PHARMA LTD
LEVOLEUCOVORIN CALCIUM	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217314	HAINAN POLY PHARM

Top