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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205197
Company: TEVA PHARMS USA INC

Products on ANDA 205197

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PLERIXAFOR	PLERIXAFOR	24MG/1.2ML (20MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205197

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/24/2023	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205197Orig1s000TA_ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/11/2024	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205197

PLERIXAFOR

SOLUTION;SUBCUTANEOUS; 24MG/1.2ML (20MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MOZOBIL	PLERIXAFOR	24MG/1.2ML (20MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	Yes	AP	022311	GENZYME
PLERIXAFOR	PLERIXAFOR	24MG/1.2ML (20MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	215334	AMNEAL
PLERIXAFOR	PLERIXAFOR	24MG/1.2ML (20MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	205182	DR REDDYS
PLERIXAFOR	PLERIXAFOR	24MG/1.2ML (20MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	213672	EUGIA PHARMA
PLERIXAFOR	PLERIXAFOR	24MG/1.2ML (20MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	206644	GLAND
PLERIXAFOR	PLERIXAFOR	24MG/1.2ML (20MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	217560	HETERO LABS LTD VI
PLERIXAFOR	PLERIXAFOR	24MG/1.2ML (20MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	215698	MEITHEAL
PLERIXAFOR	PLERIXAFOR	24MG/1.2ML (20MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	211901	MSN
PLERIXAFOR	PLERIXAFOR	24MG/1.2ML (20MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	205197	TEVA PHARMS USA INC

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