Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET;ORAL | 0.375MG | 0 | HIVID | ZALCITABINE |
| 002 | TABLET;ORAL | 0.75MG | 0 | HIVID | ZALCITABINE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1992-06-19 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 1994-10-07 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 1994-08-05 | UNKNOWN |
| LABELING; Labeling | SUPPL | 4 | AP | 1994-10-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1994-07-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1996-03-04 | |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 1996-06-26 | PRIORITY |
| LABELING; Labeling | SUPPL | 8 | AP | 1996-10-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1997-10-15 | |
| LABELING; Labeling | SUPPL | 10 | AP | 1998-03-04 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 1998-08-28 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2000-04-19 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 1999-06-01 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2002-07-03 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2002-08-14 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2002-09-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2002-08-02 | |
Submissions Property Types
| ORIG | 1 | Null | 11 |
| SUPPL | 5 | Null | 14 |
| SUPPL | 6 | Null | 14 |
| SUPPL | 9 | Null | 14 |
| SUPPL | 17 | Null | 14 |
CDER Filings
ROCHE
cder:Array
(
[0] => Array
(
[ApplNo] => 20199
[companyName] => ROCHE
[docInserts] => ["",""]
[products] => [{"drugName":"HIVID","activeIngredients":"ZALCITABINE","strength":"0.375MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HIVID","activeIngredients":"ZALCITABINE","strength":"0.75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"09\/12\/2002","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20199s16lbl.pdf\"}]","notes":""},{"actionDate":"08\/14\/2002","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20199s15lbl.pdf\"}]","notes":""},{"actionDate":"07\/03\/2002","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20199s014lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"HIVID","submission":"ZALCITABINE","actionType":"0.375MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HIVID","submission":"ZALCITABINE","actionType":"0.75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2002-09-12
)
)