Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 074973
Company: ALLEGIS

Products on NDA 074973

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PRIMSOL	TRIMETHOPRIM HYDROCHLORIDE	EQ 50MG BASE/5ML	SOLUTION;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 074973

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/24/2000	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74973ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/74973_Primsol.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/21/2016	SUPPL-8	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/2016/074973s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/74973Orig1s008ltr.pdf
09/08/2014	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
03/20/2001	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 074973

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/21/2016	SUPPL-8	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/2016/074973s008lbl.pdf