Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050719
Company: CASPER PHARMA LLC
Company: CASPER PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HELIDAC | BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE | 262.4MG,N/A,N/A;N/A,250MG,N/A;N/A,N/A,500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE, TABLET, CAPSULE;ORAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/31/2025 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050719s026lbl.pdf | |
| 07/08/2024 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050719s025lbl.pdf | |
| 12/15/2021 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050719s024lbl.pdf | |
| 03/05/2021 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050719s023lbl.pdf | |
| 03/14/2019 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050719s022lbl.pdf | |
| 08/11/2015 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050719s021lbl.pdf |
| 06/19/2012 | SUPPL-20 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050719s017s020lbl.pdf |
| 06/19/2012 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050719s017s020lbl.pdf | |
| 11/12/2009 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050719s015lbl.pdf | |
| 06/27/2008 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050719s013lbl.pdf | |
| 09/10/2004 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50719s008lbl.pdf | |
| 04/27/2003 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050719s007lbl.pdf | |
| 12/12/2002 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50719slr006_Helidac_lbl.pdf | |
| 05/15/1998 | SUPPL-2 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050719s002lbl.pdf |
| 08/15/1996 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1996/050719lbl.pdf |