NAROPIN |
020533 |
001 |
NDA |
ROPIVACAINE HYDROCHLORIDE |
SOLUTION;INJECTION |
20MG/10ML (2MG/ML) |
Yes
|
No
|
1996/09/24
|
1998/05/01
|
FRESENIUS KABI USA |
Prescription |
NAROPIN |
020533 |
002 |
NDA |
ROPIVACAINE HYDROCHLORIDE |
SOLUTION;INJECTION |
40MG/20ML (2MG/ML) |
Yes
|
No
|
1996/09/24
|
1996/09/24
|
FRESENIUS KABI USA |
Prescription |
NAROPIN |
020533 |
003 |
NDA |
ROPIVACAINE HYDROCHLORIDE |
SOLUTION;INJECTION |
100MG/20ML (5MG/ML) |
Yes
|
No
|
1996/09/24
|
1998/05/01
|
FRESENIUS KABI USA |
Prescription |
NAROPIN |
020533 |
004 |
NDA |
ROPIVACAINE HYDROCHLORIDE |
SOLUTION;INJECTION |
150MG/20ML (7.5MG/ML) |
Yes
|
No
|
1996/09/24
|
1996/09/24
|
FRESENIUS KABI USA |
Prescription |
NAROPIN |
020533 |
005 |
NDA |
ROPIVACAINE HYDROCHLORIDE |
SOLUTION;INJECTION |
100MG/10ML (10MG/ML) |
Yes
|
No
|
1996/09/24
|
1996/09/24
|
FRESENIUS KABI USA |
Prescription |
NAROPIN |
020533 |
006 |
NDA |
ROPIVACAINE HYDROCHLORIDE |
SOLUTION;INJECTION |
200MG/100ML (2MG/ML) |
Yes
|
No
|
1996/09/24
|
1996/09/24
|
FRESENIUS KABI USA |
Prescription |
NAROPIN |
020533 |
007 |
NDA |
ROPIVACAINE HYDROCHLORIDE |
SOLUTION;INJECTION |
400MG/200ML (2MG/ML) |
Yes
|
No
|
1996/09/24
|
1996/09/24
|
FRESENIUS KABI USA |
Prescription |
NAROPIN |
020533 |
008 |
NDA |
ROPIVACAINE HYDROCHLORIDE |
SOLUTION;INJECTION |
150MG/30ML (5MG/ML) |
Yes
|
No
|
1996/09/24
|
1996/09/24
|
FRESENIUS KABI USA |
Prescription |
NAROPIN |
020533 |
009 |
NDA |
ROPIVACAINE HYDROCHLORIDE |
SOLUTION;INJECTION |
500MG/100ML (5MG/ML) |
Yes
|
No
|
1996/09/24
|
2011/01/04
|
FRESENIUS KABI USA |
Prescription |
NAROPIN |
020533 |
010 |
NDA |
ROPIVACAINE HYDROCHLORIDE |
SOLUTION;INJECTION |
1GM/200ML (5MG/ML) |
Yes
|
No
|
1996/09/24
|
2011/01/04
|
FRESENIUS KABI USA |
Prescription |
NAROPIN |
020533 |
011 |
NDA |
ROPIVACAINE HYDROCHLORIDE |
SOLUTION;INJECTION |
200MG/20ML (10MG/ML) |
Yes
|
Yes
|
1996/09/24
|
1996/09/24
|
FRESENIUS KABI USA |
Prescription |
NAROPIN |
020533 |
012 |
NDA |
ROPIVACAINE HYDROCHLORIDE |
SOLUTION;INJECTION |
75MG/10ML (7.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
1996/09/24
|
1996/09/24
|
FRESENIUS KABI USA |
Discontinued |
NAROPIN |
020533 |
013 |
NDA |
ROPIVACAINE HYDROCHLORIDE |
SOLUTION;INJECTION |
50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
1996/09/24
|
1998/05/01
|
FRESENIUS KABI USA |
Discontinued |