Home Applications 020692 Application 020692
Type NDA
Sponsor GLAXOSMITHKLINE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SEREVENT SALMETEROL XINAFOATE POWDER;INHALATION EQ 0.05MG BASE/INH Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020692-001 SEREVENT SALMETEROL XINAFOATE EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19
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 1 of 2 · 41 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 2026-02-19 14:30 UTC 2026-02 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 cb3db0bc1861…
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 13 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0173-0520 SEREVENT salmeterol xinafoate GlaxoSmithKline LLC NDA Current 0173-0520 SEREVENT salmeterol xinafoate GlaxoSmithKline LLC NDA Current 0173-0520 SEREVENT salmeterol xinafoate GlaxoSmithKline LLC NDA Current 0173-0520 SEREVENT salmeterol xinafoate GlaxoSmithKline LLC NDA Current 0173-0520 SEREVENT salmeterol xinafoate GlaxoSmithKline LLC NDA Current 0173-0521 SEREVENT salmeterol xinafoate GlaxoSmithKline LLC NDA Current 0173-0521 SEREVENT salmeterol xinafoate GlaxoSmithKline LLC NDA Current 0173-0521 SEREVENT salmeterol xinafoate GlaxoSmithKline LLC NDA Current 0173-0521 SEREVENT salmeterol xinafoate GlaxoSmithKline LLC NDA Current 0173-0521 SEREVENT salmeterol xinafoate GlaxoSmithKline LLC NDA Current 0173-0521 SEREVENT salmeterol xinafoate GlaxoSmithKline LLC NDA Current 0173-0521 SEREVENT salmeterol xinafoate GlaxoSmithKline LLC NDA Current 68258-8961 SEREVENT salmeterol xinafoate Dispensing Solutions, Inc. NDA Current