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
CARBOPLATIN از شرکت HOSPIRA
Abbreviated New Drug Application (ANDA): 077059
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARBOPLATIN | CARBOPLATIN | 600MG/60ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription |
AP |
No | 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 |
|---|---|---|---|---|---|---|---|
| 11/23/2004 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/077059ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/24/2017 | SUPPL-19 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 06/07/2005 | SUPPL-3 | Labeling |
Label is not available on this site. |
CARBOPLATIN
INJECTABLE;INTRAVENOUS; 600MG/60ML (10MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBOPLATIN | CARBOPLATIN | 600MG/60ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 206775 | ACCORD HLTHCARE |
| CARBOPLATIN | CARBOPLATIN | 600MG/60ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 091268 | AKORN |
| CARBOPLATIN | CARBOPLATIN | 600MG/60ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 077861 | CIPLA LTD |
| CARBOPLATIN | CARBOPLATIN | 600MG/60ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 077266 | FRESENIUS KABI USA |
| CARBOPLATIN | CARBOPLATIN | 600MG/60ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 207324 | GLAND PHARMA LTD |
| CARBOPLATIN | CARBOPLATIN | 600MG/60ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 077244 | HIKMA |
| CARBOPLATIN | CARBOPLATIN | 600MG/60ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 077059 | HOSPIRA |
| CARBOPLATIN | CARBOPLATIN | 600MG/60ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 208487 | NOVAST LABS |
| CARBOPLATIN | CARBOPLATIN | 600MG/60ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 077269 | PHARMACHEMIE BV |
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