| OTOBIONE |
061816 |
001 |
ANDA |
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE |
SUSPENSION/DROPS;OTIC |
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML |
No
|
No
|
--
|
Approved Prior to Jan 1, 1982
|
SCHERING |
Discontinued |
| ERYTHROMYCIN LACTOBIONATE |
062604 |
001 |
ANDA |
ERYTHROMYCIN LACTOBIONATE |
INJECTABLE;INJECTION |
EQ 500MG BASE/VIAL |
No
|
No
|
--
|
1986/11/24
|
ABRAXIS PHARM |
Discontinued |
| ERYTHROMYCIN LACTOBIONATE |
062604 |
002 |
ANDA |
ERYTHROMYCIN LACTOBIONATE |
INJECTABLE;INJECTION |
EQ 1GM BASE/VIAL |
No
|
No
|
--
|
1986/11/24
|
ABRAXIS PHARM |
Discontinued |
| ERYTHROMYCIN LACTOBIONATE |
062660 |
001 |
ANDA |
ERYTHROMYCIN LACTOBIONATE |
Injectable; Injection |
EQ 500MG BASE/VIAL |
No
|
No
|
--
|
--
|
QUAD PHARMS |
Discontinued |
| ERYTHROMYCIN LACTOBIONATE |
062660 |
003 |
ANDA |
ERYTHROMYCIN LACTOBIONATE |
Injectable; Injection |
EQ 1GM BASE/VIAL |
No
|
No
|
--
|
--
|
QUAD PHARMS |
Discontinued |
| OTOBIOTIC |
062302 |
001 |
ANDA |
HYDROCORTISONE; POLYMYXIN B SULFATE |
SOLUTION/DROPS;OTIC |
5MG/ML;EQ 10,000 UNITS BASE/ML |
No
|
No
|
1981/12/01
|
Approved Prior to Jan 1, 1982
|
SCHERING |
Discontinued |
| ERYTHROMYCIN LACTOBIONATE |
062993 |
001 |
ANDA |
ERYTHROMYCIN LACTOBIONATE |
INJECTABLE;INJECTION |
EQ 500MG BASE/VIAL |
No
|
No
|
1989/05/09
|
1989/05/09
|
BAXTER HLTHCARE |
Discontinued |
| ERYTHROMYCIN LACTOBIONATE |
062993 |
002 |
ANDA |
ERYTHROMYCIN LACTOBIONATE |
INJECTABLE;INJECTION |
EQ 1GM BASE/VIAL |
No
|
No
|
1989/05/09
|
1989/05/09
|
BAXTER HLTHCARE |
Discontinued |
| ERYTHROMYCIN LACTOBIONATE |
063253 |
001 |
ANDA |
ERYTHROMYCIN LACTOBIONATE |
INJECTABLE;INJECTION |
EQ 500MG BASE/VIAL |
No
|
No
|
1993/07/30
|
1993/07/30
|
TEVA PARENTERAL |
Discontinued |
| ERYTHROMYCIN LACTOBIONATE |
063253 |
002 |
ANDA |
ERYTHROMYCIN LACTOBIONATE |
INJECTABLE;INJECTION |
EQ 1GM BASE/VIAL |
No
|
No
|
1993/07/30
|
1993/07/30
|
TEVA PARENTERAL |
Discontinued |
| TOBI |
050753 |
001 |
NDA |
TOBRAMYCIN |
SOLUTION;INHALATION |
300MG/5ML |
Yes
|
Yes
|
1997/12/22
|
1997/12/22
|
MYLAN SPECIALITY LP |
Prescription |
| TOBI PODHALER |
201688 |
001 |
NDA |
TOBRAMYCIN |
POWDER;INHALATION |
28MG |
Yes
|
Yes
|
2013/03/22
|
2013/03/22
|
MYLAN SPECIALITY LP |
Prescription |
| ERYTHROMYCIN LACTOBIONATE |
211086 |
001 |
ANDA |
ERYTHROMYCIN LACTOBIONATE |
INJECTABLE;INJECTION |
EQ 500MG BASE/VIAL |
No
|
No
|
2020/09/17
|
2020/09/17
|
EXELA PHARMA |
Discontinued |
| ERYTHROMYCIN LACTOBIONATE |
215290 |
001 |
ANDA |
ERYTHROMYCIN LACTOBIONATE |
INJECTABLE;INJECTION |
EQ 500MG BASE/VIAL |
No
|
No
|
2022/02/14
|
2022/02/14
|
NEXUS |
Prescription |