Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203723
Company: HIKMA
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 |
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 |