Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 074374
Company: ALLEGIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRIMSOL TRIMETHOPRIM HYDROCHLORIDE EQ 25MG BASE/5ML SOLUTION;ORAL Discontinued None No 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
06/23/1995 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/074374Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/17/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/17/1997 SUPPL-1 Labeling Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.

Label is not available on this site.

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