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
CYANOCOBALAMIN از شرکت SOMERSET THERAPS LLC
Abbreviated New Drug Application (ANDA): 206503
Company: SOMERSET THERAPS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription |
AP |
No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/11/2015 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/21/2020 | SUPPL-7 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/21/2020 | SUPPL-5 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 10/21/2020 | SUPPL-4 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
CYANOCOBALAMIN
INJECTABLE;INJECTION; 1MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 080737 | AM REGENT |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 213874 | AUROBINDO PHARMA LTD |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214390 | GLAND PHARMA LTD |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204829 | MYLAN LABS LTD |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212915 | SANDOZ INC |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206503 | SOMERSET THERAPS LLC |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209429 | SOMERSET THERAPS LLC |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209255 | VITRUVIAS THERAP |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 080515 | WEST-WARD PHARMS INT |
| VIBISONE | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 080557 | FRESENIUS KABI USA |
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