Home Applications 078008 Application 078008
Type ANDA
Sponsor AUROBINDO PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MELOXICAM MELOXICAM TABLET;ORAL 7.5MG No No 002 MELOXICAM MELOXICAM TABLET;ORAL 15MG No No
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 A078008-001 MELOXICAM MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 A078008-002 MELOXICAM MELOXICAM 15MG TABLET / ORAL AB 2006-10-02
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 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 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 · 17 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 16571-776 Meloxicam Meloxicam Rising Pharma Holdings, Inc. ANDA Current 16571-776 Meloxicam Meloxicam Rising Pharma Holdings, Inc. ANDA Current 16571-777 Meloxicam Meloxicam Rising Pharma Holdings, Inc. ANDA Current 16571-777 Meloxicam Meloxicam Rising Pharma Holdings, Inc. ANDA Current 65862-097 Meloxicam Meloxicam Aurobindo Pharma Limited ANDA Current 65862-097 Meloxicam Meloxicam Aurobindo Pharma Limited ANDA Current 65862-097 Meloxicam Meloxicam Aurobindo Pharma Limited ANDA Current 65862-097 Meloxicam Meloxicam Aurobindo Pharma Limited ANDA Current 65862-098 Meloxicam Meloxicam Aurobindo Pharma Limited ANDA Current 65862-098 Meloxicam Meloxicam Aurobindo Pharma Limited ANDA Current 65862-098 Meloxicam Meloxicam Aurobindo Pharma Limited ANDA Current 65862-098 Meloxicam Meloxicam Aurobindo Pharma Limited ANDA Current 66116-392 Meloxicam Meloxicam MedVantx, Inc. ANDA Current 66116-393 Meloxicam Meloxicam MedVantx, Inc. ANDA Current 67296-1250 Meloxicam Meloxicam RedPharm Drug, Inc. ANDA Current 67296-1250 Meloxicam Meloxicam RedPharm Drug, Inc. ANDA Current 67296-1250 Meloxicam Meloxicam RedPharm Drug, Inc. ANDA Current