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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210892
Company: GLAND

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	210892	GLAND
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
LEVOLEUCOVORIN CALCIUM	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217314	HAINAN POLY PHARM

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