| OXYCODONE AND ACETAMINOPHEN |
211708 |
002 |
ANDA |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
325MG;5MG |
No
|
No
|
2019/10/31
|
2019/10/31
|
GRANULES |
Discontinued |
| OXYCODONE AND ACETAMINOPHEN |
211708 |
003 |
ANDA |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
325MG;7.5MG |
No
|
No
|
2019/10/31
|
2019/10/31
|
GRANULES |
Discontinued |
| OXYCODONE AND ACETAMINOPHEN |
211708 |
004 |
ANDA |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
325MG;10MG |
No
|
No
|
2019/10/31
|
2019/10/31
|
GRANULES |
Discontinued |
| BUTALBITAL AND ACETAMINOPHEN |
213115 |
001 |
ANDA |
ACETAMINOPHEN; BUTALBITAL |
CAPSULE;ORAL |
300MG;50MG |
No
|
No
|
2019/11/22
|
2019/11/22
|
GRANULES |
Prescription |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
210817 |
001 |
ANDA |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
CAPSULE;ORAL |
300MG;50MG;40MG |
No
|
No
|
2019/12/17
|
2019/12/17
|
DR REDDYS LABS SA |
Prescription |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
212082 |
001 |
ANDA |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
CAPSULE;ORAL |
300MG;50MG;40MG |
No
|
No
|
2019/12/17
|
2019/12/17
|
LANNETT CO INC |
Prescription |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
212083 |
001 |
ANDA |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
CAPSULE;ORAL |
325MG;50MG;40MG |
No
|
No
|
2019/12/17
|
2019/12/17
|
LANNETT CO INC |
Prescription |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
211729 |
001 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;5MG |
No
|
No
|
2020/01/03
|
2020/01/03
|
GRANULES |
Discontinued |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
211729 |
002 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;7.5MG |
No
|
No
|
2020/01/03
|
2020/01/03
|
GRANULES |
Discontinued |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
211729 |
003 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;10MG |
No
|
No
|
2020/01/03
|
2020/01/03
|
GRANULES |
Discontinued |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
211690 |
001 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;5MG |
No
|
No
|
2020/02/07
|
2020/02/07
|
CEROVENE INC |
Discontinued |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
211690 |
002 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;7.5MG |
No
|
No
|
2020/02/07
|
2020/02/07
|
CEROVENE INC |
Discontinued |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
211690 |
003 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;10MG |
No
|
No
|
2020/02/07
|
2020/02/07
|
CEROVENE INC |
Discontinued |
| ADVIL DUAL ACTION WITH ACETAMINOPHEN |
211733 |
001 |
NDA |
ACETAMINOPHEN; IBUPROFEN |
TABLET;ORAL |
250MG;125MG |
Yes
|
Yes
|
2020/02/28
|
2020/02/28
|
HALEON US HOLDINGS |
Over-the-counter |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
213321 |
001 |
ANDA |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
CAPSULE;ORAL |
300MG;50MG;40MG |
No
|
No
|
2020/04/08
|
2020/04/08
|
GRANULES |
Prescription |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
213046 |
001 |
ANDA |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
CAPSULE;ORAL |
300MG;50MG;40MG |
No
|
No
|
2020/07/01
|
2020/07/01
|
TARO |
Prescription |
| BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE |
204649 |
001 |
ANDA |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE |
CAPSULE;ORAL |
325MG;50MG;40MG;30MG |
No
|
No
|
2020/07/08
|
2020/07/08
|
STRIDES PHARMA |
Prescription |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
211543 |
001 |
ANDA |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
TABLET;ORAL |
325MG;50MG;40MG |
No
|
No
|
2020/07/17
|
2020/07/17
|
NESHER PHARMS |
Discontinued |
| ACETAMINOPHEN |
213255 |
001 |
ANDA |
ACETAMINOPHEN |
SOLUTION;INTRAVENOUS |
1GM/100ML (10MG/ML) |
No
|
No
|
2020/08/07
|
2020/08/07
|
MYLAN |
Prescription |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
203647 |
001 |
ANDA |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
TABLET;ORAL |
325MG;50MG;40MG |
No
|
No
|
2020/09/21
|
2020/09/21
|
STRIDES PHARMA |
Prescription |