ESTRADIOL VALERATE |
083546 |
001 |
ANDA |
ESTRADIOL VALERATE |
INJECTABLE;INJECTION |
10MG/ML |
No
|
No
|
--
|
Approved Prior to Jan 1, 1982
|
WATSON LABS |
Discontinued |
TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE |
085860 |
001 |
ANDA |
ESTRADIOL VALERATE; TESTOSTERONE ENANTHATE |
INJECTABLE;INJECTION |
8MG/ML;180MG/ML |
No
|
No
|
--
|
Approved Prior to Jan 1, 1982
|
WATSON LABS |
Discontinued |
ESTRADIOL VALERATE |
083547 |
001 |
ANDA |
ESTRADIOL VALERATE |
INJECTABLE;INJECTION |
20MG/ML |
No
|
No
|
1979/02/28
|
Approved Prior to Jan 1, 1982
|
DR REDDYS |
Discontinued |
ESTRADIOL VALERATE |
083714 |
001 |
ANDA |
ESTRADIOL VALERATE |
INJECTABLE;INJECTION |
40MG/ML |
No
|
No
|
1979/02/28
|
Approved Prior to Jan 1, 1982
|
DR REDDYS |
Discontinued |
TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE |
085865 |
001 |
ANDA |
ESTRADIOL VALERATE; TESTOSTERONE ENANTHATE |
INJECTABLE;INJECTION |
4MG/ML;90MG/ML |
No
|
No
|
1981/05/07
|
Approved Prior to Jan 1, 1982
|
WATSON LABS |
Discontinued |
ESTRADIOL VALERATE |
040628 |
001 |
ANDA |
ESTRADIOL VALERATE |
INJECTABLE;INJECTION |
10MG/ML |
No
|
No
|
2007/10/04
|
2007/10/04
|
FOSUN PHARMA |
Discontinued |
ESTRADIOL VALERATE |
040628 |
002 |
ANDA |
ESTRADIOL VALERATE |
INJECTABLE;INJECTION |
20MG/ML |
No
|
No
|
2007/10/04
|
2007/10/04
|
FOSUN PHARMA |
Discontinued |
ESTRADIOL VALERATE |
040628 |
003 |
ANDA |
ESTRADIOL VALERATE |
INJECTABLE;INJECTION |
40MG/ML |
No
|
No
|
2007/10/04
|
2007/10/04
|
FOSUN PHARMA |
Discontinued |
ESTRADIOL VALERATE |
090920 |
001 |
ANDA |
ESTRADIOL VALERATE |
INJECTABLE;INJECTION |
20MG/ML |
No
|
No
|
2010/01/19
|
2010/01/19
|
AM REGENT |
Prescription |
ESTRADIOL VALERATE |
090920 |
002 |
ANDA |
ESTRADIOL VALERATE |
INJECTABLE;INJECTION |
40MG/ML |
No
|
No
|
2010/01/19
|
2010/01/19
|
AM REGENT |
Prescription |
ESTRADIOL VALERATE; ESTRADIOL VALERATE; DIENOGEST |
202999 |
001 |
ANDA |
ESTRADIOL VALERATE; ESTRADIOL VALERATE; DIENOGEST |
TABLET;ORAL |
1MG;2MG;2MG |
No
|
No
|
2016/03/18
(TA)
|
--
|
DR REDDYS LABS SA |
None (Tentative Approval) |
ESTRADIOL VALERATE; ESTRADIOL VALERATE; DIENOGEST |
202999 |
002 |
ANDA |
ESTRADIOL VALERATE; ESTRADIOL VALERATE; DIENOGEST |
TABLET;ORAL |
3MG;2MG;3MG |
No
|
No
|
2016/03/18
(TA)
|
--
|
DR REDDYS LABS SA |
None (Tentative Approval) |
ESTRADIOL VALERATE AND DIENOGEST |
202349 |
001 |
ANDA |
DIENOGEST; ESTRADIOL VALERATE |
TABLET;ORAL |
N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A |
No
|
No
|
2017/05/09
(TA)
|
--
|
WATSON LABS INC |
Prescription |
ESTRADIOL VALERATE |
203723 |
001 |
ANDA |
ESTRADIOL VALERATE |
INJECTABLE;INJECTION |
10MG/ML |
No
|
No
|
2020/04/21
|
2020/04/21
|
HIKMA |
Prescription |
ESTRADIOL VALERATE |
203723 |
002 |
ANDA |
ESTRADIOL VALERATE |
INJECTABLE;INJECTION |
20MG/ML |
No
|
No
|
2020/04/21
|
2020/04/21
|
HIKMA |
Prescription |
ESTRADIOL VALERATE |
203723 |
003 |
ANDA |
ESTRADIOL VALERATE |
INJECTABLE;INJECTION |
40MG/ML |
No
|
No
|
2020/04/21
|
2020/04/21
|
HIKMA |
Prescription |
ESTRADIOL VALERATE |
216656 |
001 |
ANDA |
ESTRADIOL VALERATE |
INJECTABLE;INJECTION |
10MG/ML |
No
|
No
|
2023/04/28
|
2023/04/28
|
XIROMED |
Prescription |
ESTRADIOL VALERATE |
216656 |
002 |
ANDA |
ESTRADIOL VALERATE |
INJECTABLE;INJECTION |
20MG/ML |
No
|
No
|
2023/04/28
|
2023/04/28
|
XIROMED |
Prescription |
ESTRADIOL VALERATE |
216656 |
003 |
ANDA |
ESTRADIOL VALERATE |
INJECTABLE;INJECTION |
40MG/ML |
No
|
Yes
|
2023/04/28
|
2023/04/28
|
XIROMED |
Prescription |