RELA |
012155 |
001 |
NDA |
CARISOPRODOL |
TABLET;ORAL |
350MG |
No
|
No
|
--
|
Approved Prior to Jan 1, 1982
|
SCHERING |
Discontinued |
VERELAN |
019614 |
001 |
NDA |
VERAPAMIL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
120MG |
Yes
|
No
|
1990/05/29
|
1990/05/29
|
AZURITY |
Prescription |
VERELAN |
019614 |
002 |
NDA |
VERAPAMIL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
240MG |
Yes
|
No
|
1990/05/29
|
1990/05/29
|
AZURITY |
Prescription |
VERELAN |
019614 |
003 |
NDA |
VERAPAMIL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
180MG |
Yes
|
No
|
1990/05/29
|
1992/01/09
|
AZURITY |
Prescription |
VERELAN |
019614 |
004 |
NDA |
VERAPAMIL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
360MG |
Yes
|
Yes
|
1990/05/29
|
1996/05/10
|
AZURITY |
Prescription |
RELAFEN |
019583 |
001 |
NDA |
NABUMETONE |
TABLET;ORAL |
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
1991/12/24
|
1991/12/24
|
SMITHKLINE BEECHAM |
Discontinued |
RELAFEN |
019583 |
002 |
NDA |
NABUMETONE |
TABLET;ORAL |
750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
1991/12/24
|
1991/12/24
|
SMITHKLINE BEECHAM |
Discontinued |
NAPRELAN |
020353 |
001 |
NDA |
NAPROXEN SODIUM |
TABLET, EXTENDED RELEASE;ORAL |
EQ 375MG BASE |
Yes
|
No
|
1996/01/05
|
1996/01/05
|
TWI PHARMS |
Prescription |
NAPRELAN |
020353 |
002 |
NDA |
NAPROXEN SODIUM |
TABLET, EXTENDED RELEASE;ORAL |
EQ 500MG BASE |
Yes
|
No
|
1996/01/05
|
1996/01/05
|
TWI PHARMS |
Prescription |
NAPRELAN |
020353 |
003 |
NDA |
NAPROXEN SODIUM |
TABLET, EXTENDED RELEASE;ORAL |
EQ 750MG BASE |
Yes
|
Yes
|
1996/01/05
|
1996/01/05
|
TWI PHARMS |
Prescription |
PRELAY |
020719 |
001 |
NDA |
TROGLITAZONE |
TABLET;ORAL |
200MG |
No
|
No
|
1997/01/29
|
1997/01/29
|
SANKYO |
Discontinued |
PRELAY |
020719 |
002 |
NDA |
TROGLITAZONE |
TABLET;ORAL |
400MG |
No
|
No
|
1997/01/29
|
1997/01/29
|
SANKYO |
Discontinued |
PRELAY |
020719 |
003 |
NDA |
TROGLITAZONE |
TABLET;ORAL |
300MG |
No
|
No
|
1997/01/29
|
1997/08/04
|
SANKYO |
Discontinued |
VERELAN PM |
020943 |
001 |
NDA |
VERAPAMIL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
100MG |
Yes
|
No
|
1998/11/25
|
1998/11/25
|
AZURITY |
Prescription |
VERELAN PM |
020943 |
002 |
NDA |
VERAPAMIL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
200MG |
Yes
|
No
|
1998/11/25
|
1998/11/25
|
AZURITY |
Prescription |
VERELAN PM |
020943 |
003 |
NDA |
VERAPAMIL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
300MG |
Yes
|
Yes
|
1998/11/25
|
1998/11/25
|
AZURITY |
Prescription |
VANTRELA ER |
207975 |
001 |
NDA |
HYDROCODONE BITARTRATE |
TABLET, EXTENDED RELEASE;ORAL |
15MG |
Yes
|
No
|
2017/01/17
|
2017/01/17
|
TEVA BRANDED PHARM |
Discontinued |
VANTRELA ER |
207975 |
002 |
NDA |
HYDROCODONE BITARTRATE |
TABLET, EXTENDED RELEASE;ORAL |
30MG |
Yes
|
No
|
2017/01/17
|
2017/01/17
|
TEVA BRANDED PHARM |
Discontinued |
VANTRELA ER |
207975 |
003 |
NDA |
HYDROCODONE BITARTRATE |
TABLET, EXTENDED RELEASE;ORAL |
45MG |
Yes
|
No
|
2017/01/17
|
2017/01/17
|
TEVA BRANDED PHARM |
Discontinued |
VANTRELA ER |
207975 |
004 |
NDA |
HYDROCODONE BITARTRATE |
TABLET, EXTENDED RELEASE;ORAL |
60MG |
Yes
|
No
|
2017/01/17
|
2017/01/17
|
TEVA BRANDED PHARM |
Discontinued |