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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050719
Company: CASPER PHARMA LLC

Products on NDA 050719

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262.4MG,N/A,N/A;N/A,250MG,N/A;N/A,N/A,500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE, TABLET, CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050719

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
12/15/2021	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050719s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050719Orig1s024ltr.pdf
03/05/2021	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050719s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050719Orig1s023ltr.pdf
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.

Labels for NDA 050719

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

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