Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203723
Company: HIKMA
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/21/2020 ORIG-1 Approval

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 PAR STERILE PRODUCTS
ESTRADIOL VALERATE ESTRADIOL VALERATE 10MG/ML INJECTABLE;INJECTION Prescription No AO 203723 HIKMA

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

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

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