Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050719
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262.4MG,N/A,N/A;N/A,250MG,N/A;N/A,N/A,500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, CHEWABLE, TABLET, CAPSULE;ORAL Discontinued None Yes No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
08/15/1996 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/1996/050719lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50719slr06ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/14/2019 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050719s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050719Orig1s022ltr.pdf
08/11/2015 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (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 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050719Orig1s021ltr.pdf
06/19/2012 SUPPL-20 Manufacturing (CMC) Label (PDF)
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)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050719s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050719s015ltr.pdf
06/27/2008 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050719s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050719s013ltr.pdf
07/24/2007 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050719s009ltr.pdf
09/10/2004 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50719s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50719s008ltr.pdf
04/27/2003 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050719s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50719slr007ltr.pdf
12/12/2002 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50719slr006_Helidac_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50719slr06ltr.pdf
06/30/1999 SUPPL-5 Labeling

Label is not available on this site.

07/29/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/30/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/15/1998 SUPPL-2 Manufacturing (CMC)-Control Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050719s002lbl.pdf
08/28/1997 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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