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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214596
Company: CIPLA

Products on ANDA 214596

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHYTONADIONE	PHYTONADIONE	1MG/0.5ML	INJECTABLE;INJECTION	Prescription	AB2	No	Yes
PHYTONADIONE	PHYTONADIONE	10MG/ML	INJECTABLE;INJECTION	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214596

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/22/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214596Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 214596

PHYTONADIONE

INJECTABLE;INJECTION; 1MG/0.5ML
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PHYTONADIONE	PHYTONADIONE	1MG/0.5ML	INJECTABLE;INJECTION	Prescription	No	AB2	216852	BAXTER HLTHCARE CORP
PHYTONADIONE	PHYTONADIONE	1MG/0.5ML	INJECTABLE;INJECTION	Prescription	No	AB2	214596	CIPLA

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