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Drugs@FDA: FDA-Approved Drugs

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

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 Yes

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.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/24/2024 SUPPL-2 Labeling-Package Insert, Labeling

Label is not available on this site.

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 PH HEALTH
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 PH HEALTH
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
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
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