| SOMA |
011792 |
001 |
NDA |
CARISOPRODOL |
TABLET;ORAL |
350MG |
Yes
|
No
|
1959/04/09
|
Approved Prior to Jan 1, 1982
|
MYLAN SPECIALITY LP |
Prescription |
| SOMA |
011792 |
003 |
NDA |
CARISOPRODOL |
CAPSULE;ORAL |
250MG |
Yes
|
No
|
1959/04/09
|
Approved Prior to Jan 1, 1982
|
MYLAN SPECIALITY LP |
Discontinued |
| SOMA |
011792 |
004 |
NDA |
CARISOPRODOL |
TABLET;ORAL |
250MG |
Yes
|
Yes
|
1959/04/09
|
2007/09/13
|
MYLAN SPECIALITY LP |
Prescription |
| SOMA COMPOUND |
012365 |
005 |
NDA |
ASPIRIN; CARISOPRODOL |
TABLET;ORAL |
325MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
No
|
No
|
1960/09/12
|
1983/07/11
|
MEDA PHARMS |
Discontinued |
| SOMA COMPOUND W/ CODEINE |
012366 |
002 |
NDA |
ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE |
TABLET;ORAL |
325MG;200MG;16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
No
|
No
|
1960/10/05
|
1983/07/11
|
MEDA PHARMS |
Discontinued |
| DOXIL (LIPOSOMAL) |
050718 |
001 |
NDA |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE, LIPOSOMAL;INJECTION |
20MG/10ML (2MG/ML) |
Yes
|
No
|
1995/11/17
|
1995/11/17
|
BAXTER HLTHCARE CORP |
Prescription |
| DOXIL (LIPOSOMAL) |
050718 |
002 |
NDA |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE, LIPOSOMAL;INJECTION |
50MG/25ML (2MG/ML) |
Yes
|
No
|
1995/11/17
|
2000/06/13
|
BAXTER HLTHCARE CORP |
Prescription |
| SOMAVERT |
021106 |
001 |
BLA |
PEGVISOMANT |
INJECTABLE;SUBCUTANEOUS |
10MG/VIAL |
No
|
No
|
2003/03/25
|
--
|
PHARMACIA |
Prescription |
| SOMAVERT |
021106 |
002 |
BLA |
PEGVISOMANT |
INJECTABLE;SUBCUTANEOUS |
15MG/VIAL |
No
|
No
|
2003/03/25
|
--
|
PHARMACIA |
Prescription |
| SOMAVERT |
021106 |
003 |
BLA |
PEGVISOMANT |
INJECTABLE;SUBCUTANEOUS |
20MG/VIAL |
No
|
No
|
2003/03/25
|
--
|
PHARMACIA |
Prescription |
| SOMAVERT |
021106 |
004 |
BLA |
PEGVISOMANT |
INJECTABLE;SUBCUTANEOUS |
25MG/VIAL |
No
|
No
|
2003/03/25
|
--
|
PHARMACIA |
Prescription |
| SOMAVERT |
021106 |
005 |
BLA |
PEGVISOMANT |
INJECTABLE;SUBCUTANEOUS |
30MG/VIAL |
No
|
No
|
2003/03/25
|
--
|
PHARMACIA |
Prescription |
| SOMATULINE DEPOT |
022074 |
001 |
NDA |
LANREOTIDE ACETATE |
SOLUTION;SUBCUTANEOUS |
EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) |
Yes
|
Yes
|
2007/08/30
|
2007/08/30
|
IPSEN PHARMA |
Prescription |
| SOMATULINE DEPOT |
022074 |
002 |
NDA |
LANREOTIDE ACETATE |
SOLUTION;SUBCUTANEOUS |
EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) |
Yes
|
Yes
|
2007/08/30
|
2007/08/30
|
IPSEN PHARMA |
Prescription |
| SOMATULINE DEPOT |
022074 |
003 |
NDA |
LANREOTIDE ACETATE |
SOLUTION;SUBCUTANEOUS |
EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) |
Yes
|
Yes
|
2007/08/30
|
2007/08/30
|
IPSEN PHARMA |
Prescription |
| DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) |
203263 |
001 |
ANDA |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE, LIPOSOMAL;INJECTION |
20MG/10ML (2MG/ML) |
No
|
Yes
|
2013/02/04
|
2013/02/04
|
SUN PHARM |
Prescription |
| DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) |
203263 |
002 |
ANDA |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE, LIPOSOMAL;INJECTION |
50MG/25ML (2MG/ML) |
No
|
Yes
|
2013/02/04
|
2013/02/04
|
SUN PHARM |
Prescription |
| DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) |
208657 |
001 |
ANDA |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE, LIPOSOMAL;INJECTION |
20MG/10ML (2MG/ML) |
No
|
No
|
2017/05/15
|
2017/05/15
|
DR REDDYS |
Prescription |
| DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) |
208657 |
002 |
ANDA |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE, LIPOSOMAL;INJECTION |
50MG/25ML (2MG/ML) |
No
|
No
|
2017/05/15
|
2017/05/15
|
DR REDDYS |
Prescription |
| DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) |
212299 |
001 |
ANDA |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE, LIPOSOMAL;INJECTION |
20MG/10ML (2MG/ML) |
No
|
No
|
2020/09/10
|
2020/09/10
|
ZYDUS LIFESCIENCES |
Prescription |