Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206183
Company: DR REDDYS

Products on ANDA 206183

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206183

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/10/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 206183

PRALATREXATE

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