Home Applications 021200 Application 021200
Type NDA
Sponsor ALFASIGMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZELNORM TEGASEROD MALEATE TABLET;ORAL EQ 2MG BASE Yes No 002 ZELNORM TEGASEROD MALEATE TABLET;ORAL EQ 6MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021200-001 ZELNORM TEGASEROD MALEATE EQ 2MG BASE TABLET / ORAL RLD 2002-07-24 N021200-002 ZELNORM TEGASEROD MALEATE EQ 6MG BASE TABLET / ORAL RLD 2002-07-24
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 3 of 3 · 88 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N021200-001 ZELNORM EQ 2MG BASE TABLET / ORAL RLD 2002-07-24 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021200-002 ZELNORM EQ 6MG BASE TABLET / ORAL RLD 2002-07-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021200-001 ZELNORM EQ 2MG BASE TABLET / ORAL RLD 2002-07-24 e64feba35796…2022-09-29 23:25 UTC 2022-09 N021200-002 ZELNORM EQ 6MG BASE TABLET / ORAL RLD 2002-07-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021200-001 ZELNORM EQ 2MG BASE TABLET / ORAL RLD 2002-07-24 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021200-002 ZELNORM EQ 6MG BASE TABLET / ORAL RLD 2002-07-24 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021200-001 ZELNORM EQ 2MG BASE TABLET / ORAL RLD 2002-07-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021200-002 ZELNORM EQ 6MG BASE TABLET / ORAL RLD 2002-07-24 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0525-0971 ZELNORM tegaserod Alfasigma USA, Inc. NDA Current 0525-0971 ZELNORM tegaserod Alfasigma USA, Inc. NDA Current 27505-090 Zelnorm tegaserod US WorldMeds, LLC NDA Current 27505-090 Zelnorm tegaserod US WorldMeds, LLC NDA Current