← FDA DRUG APPROVALS

FDA NDA · NDA022468

FOLOTYN

pralatrexate

Sponsor: ACROTECH BIOPHARMA

APPLICATION
NDA022468
TYPE
NDA
ORIGINAL APPROVAL
2009-09-24
LATEST ACTION
2020-10-20
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

FOLOTYN · ReferencePrescription
PRALATREXATE 20MG/ML (20MG/ML) · SOLUTION · INTRAVENOUS
FOLOTYN · ReferencePrescription
PRALATREXATE 40MG/2ML (20MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2020-10-20Labeling · Supplement 14 · standard — Letter ↗AP
2020-05-14Labeling · Supplement 13 · standard — Letter ↗AP
2016-05-13Labeling · Supplement 12 · standard — Label ↗AP
2012-05-30Labeling · Supplement 11 · standard — Letter ↗AP
2012-05-30Labeling · Supplement 10 · standard — Label ↗AP
2012-02-15Labeling · Supplement 9 · unknown — Label ↗AP
2011-01-07Labeling · Supplement 5 · unknown — Label ↗AP
2011-01-07Labeling · Supplement 3 · unknown — Letter ↗AP
2011-01-07Labeling · Supplement 4 · unknown — Letter ↗AP
2010-04-26Labeling · Supplement 1 · unknown — Label ↗AP
2009-09-24Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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