Documents
Application Sponsors
| NDA 018057 | HQ SPCLT PHARMA | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Prescription | 004 |
Application Products
| 001 | INJECTABLE;INJECTION | 10MG/VIAL | 1 | PLATINOL | CISPLATIN |
| 002 | INJECTABLE;INJECTION | 50MG/VIAL | 1 | PLATINOL | CISPLATIN |
| 003 | INJECTABLE;INJECTION | 0.5MG/ML | 1 | PLATINOL-AQ | CISPLATIN |
| 004 | INJECTABLE;INJECTION | 1MG/ML | 1 | CISPLATIN | CISPLATIN |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1978-12-19 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1979-12-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1979-12-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1980-01-31 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1980-01-31 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1980-02-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1981-01-22 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 1980-09-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1980-07-04 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 1981-03-12 | |
| EFFICACY; Efficacy | SUPPL | 12 | AP | 1981-12-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1982-06-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1983-01-13 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 1984-02-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1986-05-02 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 1985-08-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1984-07-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1984-04-04 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 1983-10-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1988-02-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1985-03-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1985-03-05 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 1985-07-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1985-09-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1987-03-05 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 1986-01-22 | |
| LABELING; Labeling | SUPPL | 39 | AP | 1986-08-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1987-06-08 | STANDARD |
| LABELING; Labeling | SUPPL | 41 | AP | 1986-08-19 | |
| LABELING; Labeling | SUPPL | 42 | AP | 1986-11-06 | |
| LABELING; Labeling | SUPPL | 43 | AP | 1987-03-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 1988-05-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 1988-01-13 | STANDARD |
| LABELING; Labeling | SUPPL | 46 | AP | 1987-04-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 47 | AP | 1988-11-08 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 1989-03-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 50 | AP | 1988-01-12 | STANDARD |
| LABELING; Labeling | SUPPL | 51 | AP | 1990-12-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 52 | AP | 1990-04-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 53 | AP | 1991-11-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 55 | AP | 1990-09-27 | STANDARD |
| LABELING; Labeling | SUPPL | 56 | AP | 1992-07-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 57 | AP | 1991-07-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 58 | AP | 1990-05-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 59 | AP | 1991-11-01 | STANDARD |
| LABELING; Labeling | SUPPL | 60 | AP | 1993-03-25 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 61 | AP | 1993-04-22 | UNKNOWN |
| LABELING; Labeling | SUPPL | 62 | AP | 1993-05-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 63 | AP | 1995-12-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 64 | AP | 1995-12-04 | STANDARD |
| LABELING; Labeling | SUPPL | 65 | AP | 1995-08-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 66 | AP | 1996-04-18 | STANDARD |
| LABELING; Labeling | SUPPL | 72 | AP | 1999-05-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 74 | AP | 2000-09-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 75 | AP | 2001-01-16 | STANDARD |
| LABELING; Labeling | SUPPL | 76 | AP | 2002-11-08 | STANDARD |
| LABELING; Labeling | SUPPL | 79 | AP | 2010-09-02 | STANDARD |
| LABELING; Labeling | SUPPL | 80 | AP | 2011-08-26 | UNKNOWN |
| LABELING; Labeling | SUPPL | 81 | AP | 2011-12-29 | 901 REQUIRED |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 82 | AP | 2014-02-06 | STANDARD |
| LABELING; Labeling | SUPPL | 83 | AP | 2015-02-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 84 | AP | 2015-03-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 85 | AP | 2015-10-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 86 | AP | 2017-01-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 89 | AP | 2019-02-22 | N/A |
| LABELING; Labeling | SUPPL | 92 | AP | 2022-03-24 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 44 | Null | 0 |
| SUPPL | 45 | Null | 0 |
| SUPPL | 47 | Null | 0 |
| SUPPL | 50 | Null | 0 |
| SUPPL | 52 | Null | 0 |
| SUPPL | 53 | Null | 0 |
| SUPPL | 55 | Null | 0 |
| SUPPL | 57 | Null | 0 |
| SUPPL | 58 | Null | 0 |
| SUPPL | 59 | Null | 0 |
| SUPPL | 63 | Null | 0 |
| SUPPL | 64 | Null | 0 |
| SUPPL | 66 | Null | 0 |
| SUPPL | 74 | Null | 0 |
| SUPPL | 75 | Null | 0 |
| SUPPL | 79 | Null | 6 |
| SUPPL | 80 | Null | 6 |
| SUPPL | 81 | Null | 6 |
| SUPPL | 82 | Null | 0 |
| SUPPL | 83 | Null | 6 |
| SUPPL | 84 | Null | 0 |
| SUPPL | 85 | Null | 0 |
| SUPPL | 89 | Null | 15 |
| SUPPL | 92 | Null | 15 |
TE Codes
CDER Filings
HQ SPCLT PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 18057
[companyName] => HQ SPCLT PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"CISPLATIN","activeIngredients":"CISPLATIN","strength":"50MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CISPLATIN","activeIngredients":"CISPLATIN","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"PLATINOL","activeIngredients":"CISPLATIN","strength":"10MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"PLATINOL-AQ","activeIngredients":"CISPLATIN","strength":"0.5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"03\/24\/2022","submission":"SUPPL-92","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/018057s092lbl.pdf\"}]","notes":""},{"actionDate":"02\/22\/2019","submission":"SUPPL-89","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/018057s089lbl.pdf\"}]","notes":""},{"actionDate":"02\/26\/2015","submission":"SUPPL-83","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/018057s083lbl.pdf\"}]","notes":""},{"actionDate":"12\/29\/2011","submission":"SUPPL-81","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/018057s081lbl.pdf\"}]","notes":""},{"actionDate":"08\/26\/2011","submission":"SUPPL-80","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/018057s080lbl.pdf\"}]","notes":""},{"actionDate":"09\/02\/2010","submission":"SUPPL-79","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/018057s079lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CISPLATIN","submission":"CISPLATIN","actionType":"50MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CISPLATIN","submission":"CISPLATIN","actionType":"1MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PLATINOL","submission":"CISPLATIN","actionType":"10MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"PLATINOL-AQ","submission":"CISPLATIN","actionType":"0.5MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2022-03-24
)
)