Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077269
Company: PHARMACHEMIE BV
Company: PHARMACHEMIE BV
| 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 |
|---|---|---|---|---|---|---|---|
| 10/14/2004 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77269ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/26/2012 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/28/2007 | SUPPL-2 | 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 | EPIC PHARMA LLC |
| 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 | 207324 | GLAND PHARMA LTD |
| CARBOPLATIN | CARBOPLATIN | 50MG/5ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 077244 | HIKMA |
| 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 |
| CARBOPLATIN | CARBOPLATIN | 50MG/5ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 077926 | SUN PHARM |
| CARBOPLATIN | CARBOPLATIN | 50MG/5ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 077861 | TEYRO LABS |
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 | EPIC PHARMA LLC |
| 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 |
| 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 |
| CARBOPLATIN | CARBOPLATIN | 150MG/15ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 077926 | SUN PHARM |
| CARBOPLATIN | CARBOPLATIN | 150MG/15ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 077861 | TEYRO LABS |
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 | EPIC PHARMA LLC |
| 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 |
| 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 |
| CARBOPLATIN | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 077926 | SUN PHARM |
| CARBOPLATIN | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 077861 | TEYRO LABS |
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 | EPIC PHARMA LLC |
| CARBOPLATIN | CARBOPLATIN | 600MG/60ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 205487 | EUGIA PHARMA |
| 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 |
| CARBOPLATIN | CARBOPLATIN | 600MG/60ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 077861 | TEYRO LABS |