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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020951
Company: GLAXOSMITHKLINE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TAGAMET HB 200 CIMETIDINE 200MG/20ML SUSPENSION;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
07/09/1999 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20951lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20951ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020951A_Tagament.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/28/2000 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.
07/24/2000 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.
03/14/2000 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/09/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20951lbl.pdf
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