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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020458
Company: TEVA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GALZIN ZINC ACETATE EQ 25MG ZINC CAPSULE;ORAL Prescription None Yes No
GALZIN ZINC ACETATE EQ 50MG ZINC CAPSULE;ORAL Prescription None Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/28/1997 ORIG-1 Approval Type 2 - New Active Ingredient STANDARD; Orphan Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020458ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/25/2024 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020458s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020458Orig1s009ltr.pdf
01/05/2016 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
05/22/2015 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
08/01/2013 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
03/14/2002 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20458s2ltr.pdf
05/19/1998 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
04/25/2024 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020458s009lbl.pdf
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