Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203563
Company: SANDOZ

Products on ANDA 203563

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	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203563

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/09/2015	ORIG-1	Approval			Label (PDF) Letter (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203563Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203563Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203563Orig1s000TAltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/06/2017	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 203563

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/09/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203563Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 203563

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