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 WEST-WARD PHARMS INT
Abbreviated New Drug Application (ANDA): 080515
Company: WEST-WARD PHARMS INT
| 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 |
|---|---|---|---|---|---|---|---|
| 10/20/1971 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/080515_cyanocobalamin_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/04/2016 | SUPPL-201 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/27/2000 | SUPPL-200 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/16/1998 | SUPPL-199 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/08/1997 | SUPPL-196 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/18/1993 | SUPPL-195 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1990 | SUPPL-194 | Labeling |
Label is not available on this site. |
||
| 05/09/1989 | SUPPL-193 | Labeling |
Label is not available on this site. |
||
| 04/26/1989 | SUPPL-192 | Labeling |
Label is not available on this site. |
||
| 04/26/1989 | SUPPL-191 | Labeling |
Label is not available on this site. |
||
| 04/03/1989 | SUPPL-190 | Labeling |
Label is not available on this site. |
||
| 11/03/1986 | SUPPL-187 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/1986 | SUPPL-185 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/03/1986 | SUPPL-184 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/1983 | SUPPL-182 | Manufacturing (CMC) |
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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