| ACETAMINOPHEN |
210969 |
001 |
ANDA |
ACETAMINOPHEN |
SOLUTION;INTRAVENOUS |
1GM/100ML (10MG/ML) |
No
|
No
|
2020/10/21
|
2020/10/21
|
EUGIA PHARMA |
Prescription |
| ACETAMINOPHEN |
206610 |
001 |
NDA |
ACETAMINOPHEN |
POWDER;INTRAVENOUS |
1GM/VIAL |
Yes
|
No
|
2021/01/15
|
2021/01/15
|
RISING |
Discontinued |
| ACETAMINOPHEN |
204957 |
001 |
NDA |
ACETAMINOPHEN |
SOLUTION;INTRAVENOUS |
500MG/50ML (10MG/ML) |
Yes
|
Yes
|
2021/02/18
|
2021/02/18
|
B BRAUN MEDICAL |
Prescription |
| ACETAMINOPHEN |
204957 |
002 |
NDA |
ACETAMINOPHEN |
SOLUTION;INTRAVENOUS |
1GM/100ML (10MG/ML) |
Yes
|
Yes
|
2021/02/18
|
2021/02/18
|
B BRAUN MEDICAL |
Prescription |
| ACETAMINOPHEN, ASPIRIN AND CAFFEINE |
214039 |
001 |
ANDA |
ACETAMINOPHEN; ASPIRIN; CAFFEINE |
TABLET;ORAL |
250MG;250MG;65MG |
No
|
No
|
2021/02/23
|
2021/02/23
|
GRANULES |
Over-the-counter |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
214087 |
001 |
ANDA |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
CAPSULE;ORAL |
300MG;50MG;40MG |
No
|
No
|
2021/08/13
|
2021/08/13
|
SENORES PHARMS |
Prescription |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
214087 |
002 |
ANDA |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
CAPSULE;ORAL |
325MG;50MG;40MG |
No
|
No
|
2021/08/13
|
2021/08/13
|
SENORES PHARMS |
Prescription |
| ACETAMINOPHEN |
215486 |
001 |
ANDA |
ACETAMINOPHEN |
TABLET, EXTENDED RELEASE;ORAL |
650MG |
No
|
No
|
2021/08/25
|
2021/08/25
|
MARKSANS PHARMA |
Over-the-counter |
| OXYCODONE AND ACETAMINOPHEN |
201448 |
001 |
ANDA |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
SOLUTION;ORAL |
325MG/5ML;5MG/5ML |
No
|
No
|
2021/08/26
|
2021/08/26
|
SANKALP LIFECARE |
Discontinued |
| ACETAMINOPHEN |
214331 |
001 |
ANDA |
ACETAMINOPHEN |
SOLUTION;INTRAVENOUS |
1GM/100ML (10MG/ML) |
No
|
No
|
2021/09/17
|
2021/09/17
|
BAXTER HLTHCARE CORP |
Prescription |
| ACETAMINOPHEN |
214331 |
002 |
ANDA |
ACETAMINOPHEN |
SOLUTION;INTRAVENOUS |
650MG/65ML (10MG/ML) |
No
|
Yes
|
2021/09/17
|
2025/05/21
|
BAXTER HLTHCARE CORP |
Prescription |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
215047 |
001 |
ANDA |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
CAPSULE;ORAL |
300MG;50MG;40MG |
No
|
No
|
2021/11/17
|
2021/11/17
|
NOVAST LABS |
Prescription |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
201295 |
001 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
SOLUTION;ORAL |
325MG/15ML;7.5MG/15ML |
No
|
No
|
2021/12/30
|
2021/12/30
|
TRIS PHARMA INC |
Discontinued |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
201295 |
002 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
SOLUTION;ORAL |
300MG/15ML;10MG/15ML |
No
|
No
|
2021/12/30
|
2021/12/30
|
TRIS PHARMA INC |
Discontinued |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
214928 |
001 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;5MG |
No
|
No
|
2021/12/30
|
2021/12/30
|
PRINSTON INC |
Discontinued |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
214928 |
002 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;7.5MG |
No
|
No
|
2021/12/30
|
2021/12/30
|
PRINSTON INC |
Discontinued |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
214928 |
003 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;10MG |
No
|
No
|
2021/12/30
|
2021/12/30
|
PRINSTON INC |
Discontinued |
| BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE |
215138 |
001 |
ANDA |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE |
CAPSULE;ORAL |
325MG;50MG;40MG;30MG |
No
|
No
|
2022/01/26
|
2022/01/26
|
HIKMA |
Prescription |
| BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE |
215138 |
002 |
ANDA |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE |
CAPSULE;ORAL |
300MG;50MG;40MG;30MG |
No
|
No
|
2022/01/26
|
2022/01/26
|
HIKMA |
Prescription |
| ACETAMINOPHEN, ASPIRIN AND CAFFEINE |
211695 |
001 |
ANDA |
ACETAMINOPHEN; ASPIRIN; CAFFEINE |
TABLET;ORAL |
250MG;250MG;65MG |
No
|
No
|
2022/02/02
|
2022/02/02
|
AUROBINDO PHARMA LTD |
Over-the-counter |