Home Applications 040442 Application 040442
Type ANDA
Sponsor MIKART Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CARBINOXAMINE MALEATE CARBINOXAMINE MALEATE TABLET;ORAL 4MG No Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A040442-001 CARBINOXAMINE MALEATE CARBINOXAMINE MALEATE 4MG TABLET / ORAL 2003-03-19
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 · 42 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 2026-08-18 06:07:40 2026-07 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL 2003-03-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 46672-191 carbinoxamine maleate carbinoxamine maleate Mikart, Inc. ANDA Current 46672-191 carbinoxamine maleate carbinoxamine maleate Mikart, LLC ANDA Current 46672-191 carbinoxamine maleate carbinoxamine maleate Mikart, LLC ANDA Current 46672-191 carbinoxamine maleate carbinoxamine maleate Mikart, LLC ANDA Current 46672-191 carbinoxamine maleate carbinoxamine maleate Mikart, LLC ANDA Current 51991-333 Carbinoxamine Maleate carbinoxamine maleate Breckenridge Pharmaceutical, Inc. ANDA Current 51991-333 Carbinoxamine Maleate carbinoxamine maleate Breckenridge Pharmaceutical, Inc. ANDA Current 51991-333 Carbinoxamine Maleate carbinoxamine maleate Breckenridge Pharmaceutical, Inc. ANDA Current 51991-333 Carbinoxamine Maleate carbinoxamine maleate Breckenridge Pharmaceutical, Inc. ANDA Current