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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022468
Company: ACROTECH BIOPHARMA

Products on NDA 022468

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FOLOTYN	PRALATREXATE	20MG/ML (20MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	No
FOLOTYN	PRALATREXATE	40MG/2ML (20MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022468

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/24/2009	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022468lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022468s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022468s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/20/2020	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022468s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022468Orig1s014ltr.pdf
05/14/2020	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022468s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022468Orig1s013ltr.pdf
05/13/2016	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022468s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022468Orig1s012ltr.pdf
05/30/2012	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022468s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022468s010,s011ltr.pdf
05/30/2012	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022468s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022468s010,s011ltr.pdf
02/15/2012	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022468s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022468s009ltr.pdf
01/07/2011	SUPPL-5	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022468s003s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022468s003,s004,s005ltr.pdf
01/07/2011	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022468s003s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022468s003,s004,s005ltr.pdf
01/07/2011	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022468s003s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022468s003,s004,s005ltr.pdf
04/26/2010	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022468s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022468s001ltr.pdf

Labels for NDA 022468

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/20/2020	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022468s014lbl.pdf
05/14/2020	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022468s013lbl.pdf
05/13/2016	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022468s012lbl.pdf
05/30/2012	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022468s010s011lbl.pdf
05/30/2012	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022468s010s011lbl.pdf
02/15/2012	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022468s009lbl.pdf
01/07/2011	SUPPL-5	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022468s003s004s005lbl.pdf
01/07/2011	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022468s003s004s005lbl.pdf
01/07/2011	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022468s003s004s005lbl.pdf
04/26/2010	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022468s001lbl.pdf
09/24/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022468lbl.pdf

Therapeutic Equivalents for NDA 022468

FOLOTYN

SOLUTION;INTRAVENOUS; 20MG/ML (20MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FOLOTYN	PRALATREXATE	20MG/ML (20MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	022468	ACROTECH BIOPHARMA
PRALATREXATE	PRALATREXATE	20MG/ML (20MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	206183	DR REDDYS

SOLUTION;INTRAVENOUS; 40MG/2ML (20MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FOLOTYN	PRALATREXATE	40MG/2ML (20MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	022468	ACROTECH BIOPHARMA
PRALATREXATE	PRALATREXATE	40MG/2ML (20MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	206183	DR REDDYS

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