| ISOPTO ATROPINE |
208151 |
001 |
NDA |
ATROPINE SULFATE |
SOLUTION/DROPS;OPHTHALMIC |
1% |
Yes
|
Yes
|
2016/12/01
|
2016/12/01
|
ALCON LABS INC |
Prescription |
| HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE |
203535 |
001 |
ANDA |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
SYRUP;ORAL |
1.5MG/5ML;5MG/5ML |
No
|
No
|
2017/02/13
|
2017/02/13
|
NOVEL LABS INC |
Prescription |
| HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE |
205731 |
001 |
ANDA |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
SYRUP;ORAL |
1.5MG/5ML;5MG/5ML |
No
|
No
|
2017/02/15
|
2017/02/15
|
PADAGIS US |
Prescription |
| HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE |
207487 |
001 |
ANDA |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
SYRUP;ORAL |
1.5MG/5ML;5MG/5ML |
No
|
Yes
|
2017/02/21
|
2017/02/21
|
ABHAI LLC |
Prescription |
| HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE |
204765 |
001 |
ANDA |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
SYRUP;ORAL |
1.5MG/5ML;5MG/5ML |
No
|
No
|
2017/03/06
|
2017/03/06
|
APOZEAL PHARMS |
Discontinued |
| HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE |
207176 |
001 |
ANDA |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
TABLET;ORAL |
1.5MG;5MG |
No
|
Yes
|
2017/08/07
|
2017/08/07
|
AVANTHI INC |
Prescription |
| ATROPINE SULFATE |
209260 |
001 |
NDA |
ATROPINE SULFATE |
SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL |
8MG/20ML (0.4MG/ML) |
Yes
|
Yes
|
2018/01/26
|
2018/01/26
|
FRESENIUS KABI USA |
Prescription |
| ATROPINE (AUTOINJECTOR) |
212319 |
001 |
NDA |
ATROPINE |
SOLUTION;INTRAMUSCULAR |
EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) |
No
|
No
|
2018/07/09
|
2018/07/09
|
RAFA LABS LTD |
Discontinued |
| DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE |
210571 |
001 |
ANDA |
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE |
TABLET;ORAL |
0.025MG;2.5MG |
No
|
No
|
2018/08/31
|
2018/08/31
|
UPSHER SMITH LABS |
Discontinued |
| DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE |
210819 |
001 |
ANDA |
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE |
TABLET;ORAL |
0.025MG;2.5MG |
No
|
No
|
2018/11/13
|
2018/11/13
|
BAYSHORE PHARMS LLC |
Prescription |
| HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE |
210663 |
001 |
ANDA |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
SYRUP;ORAL |
1.5MG/5ML;5MG/5ML |
No
|
No
|
2019/06/11
|
2019/06/11
|
NOSTRUM LABS INC |
Discontinued |
| DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE |
213413 |
001 |
ANDA |
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE |
TABLET;ORAL |
0.025MG;2.5MG |
No
|
No
|
2020/02/20
|
2020/02/20
|
LEADING |
Prescription |
| DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE |
210789 |
001 |
ANDA |
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE |
TABLET;ORAL |
0.025MG;2.5MG |
No
|
No
|
2020/06/03
|
2020/06/03
|
DR REDDYS LABS SA |
Discontinued |
| ATROPINE SULFATE |
214652 |
001 |
NDA |
ATROPINE SULFATE |
SOLUTION;INTRAVENOUS |
0.4MG/ML (0.4MG/ML) |
Yes
|
Yes
|
2020/09/29
|
2020/09/29
|
ACCORD HLTHCARE |
Prescription |
| ATROPINE SULFATE |
214652 |
002 |
NDA |
ATROPINE SULFATE |
SOLUTION;INTRAVENOUS |
1MG/ML (1MG/ML) |
Yes
|
Yes
|
2020/09/29
|
2020/09/29
|
ACCORD HLTHCARE |
Prescription |
| ATROPINE SULFATE |
212461 |
001 |
ANDA |
ATROPINE SULFATE |
SOLUTION;INTRAVENOUS |
1MG/10ML (0.1MG/ML) |
No
|
No
|
2020/10/05
|
2020/10/05
|
INTL MEDICATION SYS |
Prescription |
| DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE |
213335 |
001 |
ANDA |
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE |
TABLET;ORAL |
0.025MG;2.5MG |
No
|
No
|
2020/10/06
|
2020/10/06
|
SPECGX LLC |
Prescription |
| DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE |
207128 |
001 |
ANDA |
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE |
TABLET;ORAL |
0.025MG;2.5MG |
No
|
No
|
2020/10/21
|
2020/10/21
|
CHARTWELL RX |
Prescription |
| DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE |
211362 |
001 |
ANDA |
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE |
TABLET;ORAL |
0.025MG;2.5MG |
No
|
No
|
2021/01/27
|
2021/01/27
|
WINDER LABS LLC |
Prescription |
| ATROPINE SULFATE |
213424 |
001 |
ANDA |
ATROPINE SULFATE |
SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL |
8MG/20ML (0.4MG/ML) |
No
|
No
|
2021/03/19
|
2021/03/19
|
ACCORD HLTHCARE |
Prescription |