Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050529
Company: ROSS LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PEDIAZOLE ERYTHROMYCIN ETHYLSUCCINATE; SULFISOXAZOLE ACETYL EQ 200MG BASE/5ML;EQ 600MG BASE/5ML GRANULE;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
11/29/1979 ORIG-1 Approval Type 3 - New Dosage Form and Type 4 - New Combination 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
02/09/2004 SUPPL-33 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50529slr033ltr.pdf
06/21/1994 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

05/06/1993 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

03/11/1992 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1991 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

09/29/1992 SUPPL-21 Labeling

Label is not available on this site.

09/29/1992 SUPPL-12 Efficacy-New Indication

Label is not available on this site.

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