Home Applications 204299 Application 204299
Type ANDA
Sponsor NOVEL LABS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET;SUBLINGUAL 1.75MG No No 002 ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET;SUBLINGUAL 3.5MG No Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A204299-001 ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 A204299-002 ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 82 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 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 40032-761 ZOLPIDEM TARTRATE zolpidem tartrate Novel Laboratories, Inc. ANDA Current 40032-761 ZOLPIDEM TARTRATE zolpidem tartrate Novel Laboratories, Inc. ANDA Current 40032-762 ZOLPIDEM TARTRATE zolpidem tartrate Novel Laboratories, Inc. ANDA Current 40032-762 ZOLPIDEM TARTRATE zolpidem tartrate Novel Laboratories, Inc. ANDA Current 43386-761 ZOLPIDEM TARTRATE zolpidem tartrate Lupin Pharmaceuticals,Inc. ANDA Current 43386-761 ZOLPIDEM TARTRATE zolpidem tartrate Lupin Pharmaceuticals,Inc. ANDA Current 43386-761 ZOLPIDEM TARTRATE zolpidem tartrate Lupin Pharmaceuticals,Inc. ANDA Current 43386-762 ZOLPIDEM TARTRATE zolpidem tartrate Lupin Pharmaceuticals,Inc. ANDA Current 43386-762 ZOLPIDEM TARTRATE zolpidem tartrate Lupin Pharmaceuticals,Inc. ANDA Current 43386-762 ZOLPIDEM TARTRATE zolpidem tartrate Lupin Pharmaceuticals,Inc. ANDA Current