An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 215820
Company: DR REDDYS

Products on ANDA 215820

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHYTONADIONE	PHYTONADIONE	1MG/0.5ML	INJECTABLE;INJECTION	Prescription	AB1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215820

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/15/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 215820

PHYTONADIONE

INJECTABLE;INJECTION; 1MG/0.5ML
TE Code = AB1

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	AB1	216444	ALEMBIC
PHYTONADIONE	PHYTONADIONE	1MG/0.5ML	INJECTABLE;INJECTION	Prescription	No	AB1	216601	AMNEAL
PHYTONADIONE	PHYTONADIONE	1MG/0.5ML	INJECTABLE;INJECTION	Prescription	No	AB1	214966	CIPLA
PHYTONADIONE	PHYTONADIONE	1MG/0.5ML	INJECTABLE;INJECTION	Prescription	No	AB1	215820	DR REDDYS
PHYTONADIONE	PHYTONADIONE	1MG/0.5ML	INJECTABLE;INJECTION	Prescription	Yes	AB1	083722	INTL MEDICATION
PHYTONADIONE	PHYTONADIONE	1MG/0.5ML	INJECTABLE;INJECTION	Prescription	No	AB1	216298	ORBICULAR

Top