Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216656
Company: XIROMED

Products on ANDA 216656

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESTRADIOL VALERATE	ESTRADIOL VALERATE	10MG/ML	INJECTABLE;INJECTION	Prescription	AO	No	No
ESTRADIOL VALERATE	ESTRADIOL VALERATE	20MG/ML	INJECTABLE;INJECTION	Prescription	AO	No	No
ESTRADIOL VALERATE	ESTRADIOL VALERATE	40MG/ML	INJECTABLE;INJECTION	Prescription	AO	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216656

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/28/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216656

ESTRADIOL VALERATE

INJECTABLE;INJECTION; 10MG/ML
TE Code = AO

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DELESTROGEN	ESTRADIOL VALERATE	10MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AO	009402	PAR STERILE PRODUCTS
ESTRADIOL VALERATE	ESTRADIOL VALERATE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	203723	HIKMA
ESTRADIOL VALERATE	ESTRADIOL VALERATE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	216656	XIROMED

INJECTABLE;INJECTION; 20MG/ML
TE Code = AO

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DELESTROGEN	ESTRADIOL VALERATE	20MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AO	009402	PAR STERILE PRODUCTS
ESTRADIOL VALERATE	ESTRADIOL VALERATE	20MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	090920	AM REGENT
ESTRADIOL VALERATE	ESTRADIOL VALERATE	20MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	203723	HIKMA
ESTRADIOL VALERATE	ESTRADIOL VALERATE	20MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	216656	XIROMED

INJECTABLE;INJECTION; 40MG/ML
TE Code = AO

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DELESTROGEN	ESTRADIOL VALERATE	40MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AO	009402	PAR STERILE PRODUCTS
ESTRADIOL VALERATE	ESTRADIOL VALERATE	40MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	090920	AM REGENT
ESTRADIOL VALERATE	ESTRADIOL VALERATE	40MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	203723	HIKMA
ESTRADIOL VALERATE	ESTRADIOL VALERATE	40MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	216656	XIROMED