Home Applications 215328 Application 215328
Type ANDA
Sponsor PADAGIS ISRAEL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BUDESONIDE BUDESONIDE AEROSOL, FOAM;RECTAL 2MG/ACTUATION No 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 A215328-001 BUDESONIDE BUDESONIDE 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RS 2023-04-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215328-001 AB
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.
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 A215328-001 BUDESONIDE 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RS 2023-04-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215328-001 BUDESONIDE 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RS 2023-04-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215328-001 BUDESONIDE 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RS 2023-04-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215328-001 BUDESONIDE 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RS 2023-04-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215328-001 BUDESONIDE 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RS 2023-04-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215328-001 BUDESONIDE 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RS 2023-04-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215328-001 BUDESONIDE 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RS 2023-04-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215328-001 BUDESONIDE 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RS 2023-04-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215328-001 BUDESONIDE 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RS 2023-04-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215328-001 BUDESONIDE 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RS 2023-04-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215328-001 BUDESONIDE 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RS 2023-04-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215328-001 BUDESONIDE 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RS 2023-04-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215328-001 BUDESONIDE 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB 2023-04-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215328-001 BUDESONIDE 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB 2023-04-12 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215328-001 BUDESONIDE 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB 2023-04-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215328-001 BUDESONIDE 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB 2023-04-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215328-001 BUDESONIDE 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB 2023-04-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215328-001 BUDESONIDE 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB 2023-04-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215328-001 BUDESONIDE 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB 2023-04-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215328-001 BUDESONIDE 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB 2023-04-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215328-001 BUDESONIDE 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB 2023-04-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215328-001 BUDESONIDE 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB 2023-04-12 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215328-001 BUDESONIDE 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RS 2023-04-12 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2023-12-20 04:57 UTC 2023-12 A215328-001 CGT 2023-10-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215328-001 CGT 2023-10-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215328-001 CGT 2023-10-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215328-001 CGT 2023-10-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215328-001 CGT 2023-10-24 3f0d92c62455…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BUDESONIDE BUDESONIDE Padagis Israel Pharmaceuticals Ltd ad4a68e7-9200-4f05-8058-714d5d8900f8 2023-04-17 Warnings, Adverse reactions Exact identifier application applno (ANDA): 215328 application number: ANDA215328
Documents# Document, Submission type, Date table Document Submission type Date 74149 ORIG 2023-05-02