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 HIKMA PHARMS
Abbreviated New Drug Application (ANDA): 077244
Company: HIKMA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARBOPLATIN | CARBOPLATIN | 50MG/5ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription |
AP |
No | No |
| CARBOPLATIN | CARBOPLATIN | 150MG/15ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription |
AP |
No | No |
| CARBOPLATIN | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription |
AP |
No | No |
| CARBOPLATIN | CARBOPLATIN | 600MG/60ML (10MG/ML) | INJECTABLE;INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|---|
| 10/15/2004 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77244ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/13/2012 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/07/2011 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/20/2006 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 01/20/2006 | SUPPL-2 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 07/11/2005 | SUPPL-1 | Labeling |
Label is not available on this site. |
CARBOPLATIN
INJECTABLE;INTRAVENOUS; 50MG/5ML (10MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBOPLATIN | CARBOPLATIN | 50MG/5ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 206775 | ACCORD HLTHCARE |
| CARBOPLATIN | CARBOPLATIN | 50MG/5ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 090475 | AKORN |
| CARBOPLATIN | CARBOPLATIN | 50MG/5ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 077861 | CIPLA LTD |
| CARBOPLATIN | CARBOPLATIN | 50MG/5ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 205487 | EUGIA PHARMA |
| CARBOPLATIN | CARBOPLATIN | 50MG/5ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 077244 | HIKMA PHARMS |
| CARBOPLATIN | CARBOPLATIN | 50MG/5ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 076517 | HOSPIRA |
| CARBOPLATIN | CARBOPLATIN | 50MG/5ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 208487 | NOVAST LABS |
| CARBOPLATIN | CARBOPLATIN | 50MG/5ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 077269 | PHARMACHEMIE BV |
| CARBOPLATIN | CARBOPLATIN | 50MG/5ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 078280 | SANDOZ INC |
| CARBOPLATIN | CARBOPLATIN | 50MG/5ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 077926 | SUN PHARM |
INJECTABLE;INTRAVENOUS; 150MG/15ML (10MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBOPLATIN | CARBOPLATIN | 150MG/15ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 206775 | ACCORD HLTHCARE |
| CARBOPLATIN | CARBOPLATIN | 150MG/15ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 090475 | AKORN |
| CARBOPLATIN | CARBOPLATIN | 150MG/15ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 077861 | CIPLA LTD |
| CARBOPLATIN | CARBOPLATIN | 150MG/15ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 205487 | EUGIA PHARMA |
| CARBOPLATIN | CARBOPLATIN | 150MG/15ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 207324 | GLAND PHARMA LTD |
| CARBOPLATIN | CARBOPLATIN | 150MG/15ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 077244 | HIKMA PHARMS |
| CARBOPLATIN | CARBOPLATIN | 150MG/15ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 076517 | HOSPIRA |
| CARBOPLATIN | CARBOPLATIN | 150MG/15ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 208487 | NOVAST LABS |
| CARBOPLATIN | CARBOPLATIN | 150MG/15ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 077269 | PHARMACHEMIE BV |
| CARBOPLATIN | CARBOPLATIN | 150MG/15ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 078280 | SANDOZ INC |
| CARBOPLATIN | CARBOPLATIN | 150MG/15ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 077926 | SUN PHARM |
INJECTABLE;INTRAVENOUS; 450MG/45ML (10MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBOPLATIN | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 206775 | ACCORD HLTHCARE |
| CARBOPLATIN | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 090475 | AKORN |
| CARBOPLATIN | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 077861 | CIPLA LTD |
| CARBOPLATIN | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 205487 | EUGIA PHARMA |
| CARBOPLATIN | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 077247 | FRESENIUS KABI USA |
| CARBOPLATIN | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 077266 | FRESENIUS KABI USA |
| CARBOPLATIN | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 207324 | GLAND PHARMA LTD |
| CARBOPLATIN | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 077244 | HIKMA PHARMS |
| CARBOPLATIN | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 076517 | HOSPIRA |
| CARBOPLATIN | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 208487 | NOVAST LABS |
| CARBOPLATIN | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 077269 | PHARMACHEMIE BV |
| CARBOPLATIN | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 078280 | SANDOZ INC |
| CARBOPLATIN | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 077926 | SUN PHARM |
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 PHARMS |
| 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 |
حتما بخوانید : CARBOPLATIN از شرکت TEVA PHARMS USA
منبع : www.accessdata.fda.gov
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