اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
BLOXIVERZ از شرکت EXELA PHARMA
New Drug Application (NDA): 204078
Company: EXELA PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BLOXIVERZ | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription |
AP |
Yes | Yes |
| BLOXIVERZ | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription |
AP |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/31/2013 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204078s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/19/2021 | SUPPL-10 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204078s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204078orig1s010ltr.pdf |
||
| 10/20/2015 | SUPPL-7 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204078s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204078Orig1s007ltr.pdf |
||
| 12/02/2014 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/2014 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/2014 | SUPPL-4 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204078s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204078Orig1s004ltr.pdf |
||
| 09/22/2014 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/18/2014 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/19/2021 | SUPPL-10 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204078s010lbl.pdf | |
| 10/20/2015 | SUPPL-7 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204078s007lbl.pdf | |
| 12/11/2014 | SUPPL-4 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204078s004lbl.pdf | |
| 05/31/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204078s000lbl.pdf |
BLOXIVERZ
SOLUTION;INTRAVENOUS; 5MG/10ML (0.5MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BLOXIVERZ | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 204078 | EXELA PHARMA |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 209182 | AM REGENT |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 210051 | AMNEAL |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 209933 | AMPHASTAR PHARMS INC |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 210989 | AMRING PHARMS |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 212512 | BE PHARMS |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 213074 | CAPLIN |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 209135 | DR REDDYS |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 207042 | EUROHLTH INTL SARL |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 212968 | GLAND PHARMA LTD |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 210652 | INDOCO |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 212804 | MEITHEAL |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 208405 | PAR STERILE PRODUCTS |
SOLUTION;INTRAVENOUS; 10MG/10ML (1MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BLOXIVERZ | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 204078 | EXELA PHARMA |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 209182 | AM REGENT |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 210051 | AMNEAL |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 209933 | AMPHASTAR PHARMS INC |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 210989 | AMRING PHARMS |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 212512 | BE PHARMS |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 213074 | CAPLIN |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 209135 | DR REDDYS |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 207042 | EUROHLTH INTL SARL |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 212968 | GLAND PHARMA LTD |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 210652 | INDOCO |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 212804 | MEITHEAL |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 208405 | PAR STERILE PRODUCTS |
نظرات کاربران