Home Applications 074131 Application 074131
Type ANDA
Sponsor TEVA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PIROXICAM PIROXICAM CAPSULE;ORAL 10MG No No 002 PIROXICAM PIROXICAM CAPSULE;ORAL 20MG 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 A074131-001 PIROXICAM PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 A074131-002 PIROXICAM PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11
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 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 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 · 25 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0093-0756 Piroxicam Piroxicam Teva Pharmaceuticals USA, Inc. ANDA Current 0093-0756 Piroxicam Piroxicam Teva Pharmaceuticals USA, Inc. ANDA Current 0093-0756 Piroxicam Piroxicam Teva Pharmaceuticals USA, Inc. ANDA Current 0093-0756 Piroxicam Piroxicam Teva Pharmaceuticals USA, Inc. ANDA Current 0093-0756 Piroxicam Piroxicam Teva Pharmaceuticals USA, Inc. ANDA Current 0093-0757 Piroxicam Piroxicam Teva Pharmaceuticals USA, Inc. ANDA Current 0093-0757 Piroxicam Piroxicam Teva Pharmaceuticals USA, Inc. ANDA Current 0093-0757 Piroxicam Piroxicam Teva Pharmaceuticals USA, Inc. ANDA Current 0093-0757 Piroxicam Piroxicam Teva Pharmaceuticals USA, Inc. ANDA Current 0093-0757 Piroxicam Piroxicam Teva Pharmaceuticals USA, Inc. ANDA Current 21695-285 Piroxicam Piroxicam Rebel Distributors Corp ANDA Current 21695-520 Piroxicam Piroxicam Rebel Distributors Corp ANDA Current 42291-674 Piroxicam Piroxicam AvKARE, Inc. ANDA Current 42291-674 Piroxicam Piroxicam AvKARE ANDA Current 42291-674 Piroxicam Piroxicam AvKARE ANDA Current 42291-677 Piroxicam Piroxicam AvKARE, Inc. ANDA Current 42291-677 Piroxicam Piroxicam AvKARE ANDA Current 42291-677 Piroxicam Piroxicam AvKARE ANDA Current 50090-3295 Piroxicam Piroxicam A-S Medication Solutions ANDA Current 52959-232 Piroxicam Piroxicam H.J. Harkins Company, Inc. ANDA Current 52959-398 Piroxicam Piroxicam H.J. Harkins Company, Inc. ANDA Current 55289-052 Piroxicam Piroxicam PD-Rx Pharmaceuticals, Inc. ANDA Current 55700-425 Piroxicam Piroxicam Lake Erie Medical DBA Quality Care Products LLC ANDA Current 67544-807 Piroxicam Piroxicam Aphena Pharma Solutions - Tennessee, LLC ANDA Current 68387-700 Feldene Piroxicam Keltman Pharmaceuticals Inc. ANDA Current