Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074735
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CISPLATIN | CISPLATIN | 1MG/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 07/16/1999 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74735ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/19/2020 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/13/2012 | SUPPL-11 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/08/2011 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/05/2002 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 02/22/2002 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/05/2001 | SUPPL-3 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
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 | No | AP | 075036 | HIKMA |
| 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 |