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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017681
Company: SS PHARMA

Products on NDA 017681

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HIPREX	METHENAMINE HIPPURATE	1GM	TABLET;ORAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017681

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/09/1976	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/28/2021	SUPPL-19	Manufacturing (CMC)-Facility	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017681Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/017681Orig1s019ltr.pdf
12/01/2017	SUPPL-18	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/2017/017681s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017681Orig1s018ltr.pdf
08/01/2016	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
11/21/2005	SUPPL-14	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/17681s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/17681s014ltr.pdf
06/10/2004	SUPPL-13	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17681slr013_hiprex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17681slr013ltr.pdf
08/09/1988	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
04/28/1988	SUPPL-10	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/03/1989	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
05/03/1984	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
04/25/1984	SUPPL-7	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/26/1982	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
03/19/1981	SUPPL-5	Labeling		Label is not available on this site.
11/25/1980	SUPPL-4	Labeling		Label is not available on this site.
11/25/1980	SUPPL-3	Labeling		Label is not available on this site.
02/27/1978	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
02/24/1978	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 017681

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/28/2021	SUPPL-19	Manufacturing (CMC)-Facility	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017681Orig1s019lbl.pdf
12/01/2017	SUPPL-18	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/2017/017681s018lbl.pdf
11/21/2005	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/17681s014lbl.pdf
06/10/2004	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17681slr013_hiprex_lbl.pdf

Therapeutic Equivalents for NDA 017681

HIPREX

TABLET;ORAL; 1GM
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HIPREX	METHENAMINE HIPPURATE	1GM	TABLET;ORAL	Prescription	Yes	AB	017681	SS PHARMA
METHENAMINE HIPPURATE	METHENAMINE HIPPURATE	1GM	TABLET;ORAL	Prescription	No	AB	205661	AUROBINDO PHARMA LTD
METHENAMINE HIPPURATE	METHENAMINE HIPPURATE	1GM	TABLET;ORAL	Prescription	No	AB	217675	JUBILANT CADISTA
METHENAMINE HIPPURATE	METHENAMINE HIPPURATE	1GM	TABLET;ORAL	Prescription	No	AB	212172	MICRO LABS
METHENAMINE HIPPURATE	METHENAMINE HIPPURATE	1GM	TABLET;ORAL	Prescription	No	AB	210068	NOVAST LABS
UREX	METHENAMINE HIPPURATE	1GM	TABLET;ORAL	Prescription	No	AB	016151	ALVOGEN

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