Documents
Application Sponsors
| NDA 050719 | CASPER PHARMA LLC | |
Marketing Status
Application Products
| 001 | TABLET, CHEWABLE, TABLET, CAPSULE;ORAL | 262.4MG,N/A,N/A;N/A,250MG,N/A;N/A,N/A,500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | HELIDAC | BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 1996-08-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1998-05-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1998-10-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1999-07-29 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1999-06-30 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2002-12-12 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2003-04-27 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2004-09-10 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2007-07-24 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2008-06-27 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2009-11-12 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2012-06-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2012-06-19 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2015-08-11 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| LABELING; Labeling | SUPPL | 22 | AP | 2019-03-14 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2021-03-05 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2021-12-15 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 15 | Null | 7 |
| SUPPL | 17 | Null | 15 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 15 |
| SUPPL | 22 | Null | 6 |
| SUPPL | 23 | Null | 6 |
| SUPPL | 24 | Null | 7 |
CDER Filings
CASPER PHARMA LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 50719
[companyName] => CASPER PHARMA LLC
[docInserts] => ["",""]
[products] => [{"drugName":"HELIDAC","activeIngredients":"BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE","strength":"262.4MG,N\/A,N\/A;N\/A,250MG,N\/A;N\/A,N\/A,500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, CHEWABLE, TABLET, CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"03\/14\/2019","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050719s022lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/2015","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050719s021lbl.pdf\"}]","notes":"Please see"},{"actionDate":"06\/19\/2012","submission":"SUPPL-20","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/050719s017s020lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"06\/19\/2012","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/050719s017s020lbl.pdf\"}]","notes":""},{"actionDate":"11\/12\/2009","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/050719s015lbl.pdf\"}]","notes":""},{"actionDate":"06\/27\/2008","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/050719s013lbl.pdf\"}]","notes":""},{"actionDate":"09\/10\/2004","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/50719s008lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2003","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/050719s007lbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2002","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/50719slr006_Helidac_lbl.pdf\"}]","notes":""},{"actionDate":"05\/15\/1998","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050719s002lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"08\/15\/1996","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1996\\\/050719lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"HELIDAC","submission":"BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE","actionType":"262.4MG,N\/A,N\/A;N\/A,250MG,N\/A;N\/A,N\/A,500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, CHEWABLE, TABLET, CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-03-14
)
)