Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021200
Company: ALFASIGMA
Company: ALFASIGMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZELNORM | TEGASEROD MALEATE | EQ 2MG BASE | TABLET;ORAL | Discontinued | None | Yes | No |
ZELNORM | TEGASEROD MALEATE | EQ 6MG BASE | TABLET;ORAL | Discontinued | None | Yes | No |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/29/2019 | SUPPL-15 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021200Orig1s015lbl.pdf | |
03/01/2007 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021200s014lbl.pdf | |
08/21/2004 | SUPPL-5 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21200s005lbl.pdf | |
06/15/2004 | SUPPL-6 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21200scm006_zelnorm_lbl.pdf |
04/21/2004 | SUPPL-8 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21200scp007,scf008_zelnorm_lbl.pdf | |
04/21/2004 | SUPPL-7 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21200scp007,scf008_zelnorm_lbl.pdf | |
04/15/2004 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021200s009lbl.pdf | |
07/24/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21200lbl.pdf |