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
CISPLATIN از شرکت WEST-WARD PHARMS INT
Abbreviated New Drug Application (ANDA): 075036
Company: WEST-WARD PHARMS INT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CISPLATIN | CISPLATIN | 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 |
|---|---|---|---|---|---|---|---|
| 11/07/2000 | ORIG-1 | Approval |
|
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-036_Cisplatin_prntlbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/24/2018 | SUPPL-12 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 03/15/2012 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/30/2012 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/08/2011 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/21/2004 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 06/21/2004 | SUPPL-2 |
Label is not available on this site. |
|||
| 05/14/2001 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/07/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-036_Cisplatin_prntlbl.pdf |
CISPLATIN
INJECTABLE;INJECTION; 1MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CISPLATIN | CISPLATIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206774 | ACCORD HLTHCARE |
| CISPLATIN | CISPLATIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074735 | FRESENIUS KABI USA |
| CISPLATIN | CISPLATIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 207323 | GLAND PHARMA LTD |
| CISPLATIN | CISPLATIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018057 | HQ SPCLT PHARMA |
| CISPLATIN | CISPLATIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074656 | PHARMACHEMIE BV |
| CISPLATIN | CISPLATIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075036 | WEST-WARD PHARMS INT |
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