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
CYCLOSPORINE از شرکت WEST-WARD PHARMS INT
Abbreviated New Drug Application (ANDA): 065004
Company: WEST-WARD PHARMS INT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CYCLOSPORINE | CYCLOSPORINE | 50MG/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 |
---|---|---|---|---|---|---|---|
10/29/1999 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/65004LTR.PDF |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/18/2010 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
09/23/2010 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
04/03/2001 | SUPPL-2 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
04/30/2002 | SUPPL-1 | Labeling |
Label is not available on this site. |
CYCLOSPORINE
INJECTABLE;INJECTION; 50MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CYCLOSPORINE | CYCLOSPORINE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 065151 | PADAGIS US |
CYCLOSPORINE | CYCLOSPORINE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 065004 | WEST-WARD PHARMS INT |
SANDIMMUNE | CYCLOSPORINE | 50MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 050573 | NOVARTIS |
نظرات کاربران