Drugs@FDA: FDA-Approved Drugs
Company: HQ SPCLT PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CISPLATIN | CISPLATIN | 50MG/VIAL | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| CISPLATIN | CISPLATIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | No |
| PLATINOL | CISPLATIN | 10MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| PLATINOL-AQ | CISPLATIN | 0.5MG/ML | INJECTABLE;INJECTION | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 12/19/1978 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/24/2022 | SUPPL-92 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018057s092lbl.pdf | |
| 02/22/2019 | SUPPL-89 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018057s089lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018057Orig1s089ltr.pdf | |
| 01/19/2017 | SUPPL-86 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/06/2015 | SUPPL-85 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/03/2015 | SUPPL-84 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/26/2015 | SUPPL-83 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018057s083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018057Orig1s083ltr.pdf | |
| 02/06/2014 | SUPPL-82 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/29/2011 | SUPPL-81 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018057s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018057s081ltr.pdf | |
| 08/26/2011 | SUPPL-80 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018057s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018057s080ltr.pdf | |
| 09/02/2010 | SUPPL-79 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018057s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018057s079ltr.pdf | |
| 11/08/2002 | SUPPL-76 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18057slr076ltr.pdf |
| 01/16/2001 | SUPPL-75 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/13/2000 | SUPPL-74 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/05/1999 | SUPPL-72 | Labeling |
Label is not available on this site. |
||
| 04/18/1996 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/09/1995 | SUPPL-65 | Labeling |
Label is not available on this site. |
||
| 12/04/1995 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/1995 | SUPPL-63 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/17/1993 | SUPPL-62 | Labeling |
Label is not available on this site. |
||
| 04/22/1993 | SUPPL-61 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 03/25/1993 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 11/01/1991 | SUPPL-59 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/29/1990 | SUPPL-58 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/11/1991 | SUPPL-57 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/27/1992 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 09/27/1990 | SUPPL-55 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/27/1991 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/04/1990 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/1990 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 01/12/1988 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/02/1989 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 11/08/1988 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/10/1987 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 01/13/1988 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/05/1988 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/23/1987 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 11/06/1986 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 08/19/1986 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 06/08/1987 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/26/1986 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 01/22/1986 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 03/05/1987 | SUPPL-35 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/16/1985 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/03/1985 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 03/05/1985 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/05/1985 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/11/1988 | SUPPL-27 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 10/31/1983 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 04/04/1984 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/18/1984 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/23/1985 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 05/02/1986 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/27/1984 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 01/13/1983 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/10/1982 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/29/1981 | SUPPL-12 | Efficacy |
Label is not available on this site. |
||
| 03/12/1981 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 07/04/1980 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/16/1980 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 01/22/1981 | SUPPL-7 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 02/26/1980 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 01/31/1980 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/31/1980 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/05/1979 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/18/1979 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 09/11/1979 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/24/2022 | SUPPL-92 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018057s092lbl.pdf | |
| 02/22/2019 | SUPPL-89 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018057s089lbl.pdf | |
| 02/26/2015 | SUPPL-83 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018057s083lbl.pdf | |
| 12/29/2011 | SUPPL-81 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018057s081lbl.pdf | |
| 08/26/2011 | SUPPL-80 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018057s080lbl.pdf | |
| 09/02/2010 | SUPPL-79 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018057s079lbl.pdf |
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 |
PLATINOL
There are no Therapeutic Equivalents.
PLATINOL-AQ
There are no Therapeutic Equivalents.