Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077059
Company: HOSPIRA
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 |
Letter (PDF)
|
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 |
---|---|---|---|---|---|
06/07/2024 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
07/24/2017 | SUPPL-19 | Labeling-Container/Carton Labels, Labeling-Package Insert |
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 | 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 |