| TRAL |
010599 |
001 |
NDA |
HEXOCYCLIUM METHYLSULFATE |
TABLET;ORAL |
25MG |
No
|
No
|
1957/02/13
|
Approved Prior to Jan 1, 1982
|
ABBVIE |
Discontinued |
| INTRALIPID 10% |
017643 |
001 |
NDA |
SOYBEAN OIL |
INJECTABLE;INJECTION |
10% |
Yes
|
No
|
1975/10/07
|
Approved Prior to Jan 1, 1982
|
FRESENIUS |
Discontinued |
| ULTRALENTE |
018385 |
001 |
NDA |
INSULIN ZINC SUSP EXTENDED PURIFIED BEEF |
INJECTABLE;INJECTION |
100 UNITS/ML |
No
|
No
|
1980/03/17
|
--
|
NOVO NORDISK INC |
Discontinued |
| INTRALIPID 20% |
018449 |
001 |
NDA |
SOYBEAN OIL |
INJECTABLE;INJECTION |
20% |
Yes
|
Yes
|
1981/01/23
|
Approved Prior to Jan 1, 1982
|
FRESENIUS |
Prescription |
| SECTRAL |
018917 |
001 |
NDA |
ACEBUTOLOL HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
1984/12/28
|
1984/12/28
|
PROMIUS PHARMA |
Discontinued |
| SECTRAL |
018917 |
003 |
NDA |
ACEBUTOLOL HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
1984/12/28
|
1984/12/28
|
PROMIUS PHARMA |
Discontinued |
| INTRALIPID 30% |
019942 |
001 |
NDA |
SOYBEAN OIL |
INJECTABLE;INJECTION |
30% |
Yes
|
Yes
|
1993/12/30
|
1993/12/30
|
FRESENIUS |
Prescription |
| INTRALIPID 20% |
020248 |
001 |
NDA |
SOYBEAN OIL |
INJECTABLE;INJECTION |
20% |
Yes
|
Yes
|
1996/08/07
|
1996/08/07
|
FRESENIUS |
Prescription |
| UROXATRAL |
021287 |
001 |
NDA |
ALFUZOSIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG |
Yes
|
Yes
|
2003/06/12
|
2003/06/12
|
CONCORDIA |
Prescription |
| SERTRALINE HYDROCHLORIDE |
076540 |
001 |
ANDA |
SERTRALINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 25MG BASE |
No
|
No
|
2004/07/15
(TA)
|
2007/03/20
|
MYLAN PHARMS INC |
Discontinued |
| SERTRALINE HYDROCHLORIDE |
076540 |
002 |
ANDA |
SERTRALINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 50MG BASE |
No
|
No
|
2004/07/15
(TA)
|
2007/03/20
|
MYLAN PHARMS INC |
Discontinued |
| SERTRALINE HYDROCHLORIDE |
076540 |
003 |
ANDA |
SERTRALINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 100MG BASE |
No
|
No
|
2004/07/15
(TA)
|
2007/03/20
|
MYLAN PHARMS INC |
Discontinued |
| SERTRALINE HYDROCHLORIDE |
075719 |
001 |
ANDA |
SERTRALINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 50MG BASE |
No
|
No
|
2006/06/30
|
2006/06/30
|
IVAX SUB TEVA PHARMS |
Discontinued |
| SERTRALINE HYDROCHLORIDE |
075719 |
002 |
ANDA |
SERTRALINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 100MG BASE |
No
|
No
|
2006/06/30
|
2006/06/30
|
IVAX SUB TEVA PHARMS |
Discontinued |
| SERTRALINE HYDROCHLORIDE |
075719 |
003 |
ANDA |
SERTRALINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 25MG BASE |
No
|
No
|
2006/06/30
|
2006/06/30
|
IVAX SUB TEVA PHARMS |
Discontinued |
| SERTRALINE HYDROCHLORIDE |
076934 |
001 |
ANDA |
SERTRALINE HYDROCHLORIDE |
CONCENTRATE;ORAL |
EQ 20MG BASE/ML |
No
|
No
|
2006/06/30
|
2006/06/30
|
STRIDES PHARMA |
Prescription |
| SERTRALINE HYDROCHLORIDE |
076465 |
001 |
ANDA |
SERTRALINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 25MG BASE |
No
|
No
|
2006/08/11
|
2006/08/11
|
HERITAGE PHARMA AVET |
Prescription |
| SERTRALINE HYDROCHLORIDE |
076465 |
002 |
ANDA |
SERTRALINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 50MG BASE |
No
|
No
|
2006/08/11
|
2006/08/11
|
HERITAGE PHARMA AVET |
Prescription |
| SERTRALINE HYDROCHLORIDE |
076465 |
003 |
ANDA |
SERTRALINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 100MG BASE |
No
|
No
|
2006/08/11
|
2006/08/11
|
HERITAGE PHARMA AVET |
Prescription |
| SERTRALINE HYDROCHLORIDE |
078053 |
001 |
ANDA |
SERTRALINE HYDROCHLORIDE |
CONCENTRATE;ORAL |
EQ 20MG BASE/ML |
No
|
No
|
2006/11/30
(TA)
|
2007/02/05
|
RANBAXY LABS LTD |
Discontinued |