Home Applications 212548 Application 212548
Type ANDA
Sponsor XIROMED Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FOSFOMYCIN TROMETHAMINE FOSFOMYCIN TROMETHAMINE FOR SOLUTION;ORAL EQ 3GM BASE/PACKET No No
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 A212548-001 FOSFOMYCIN TROMETHAMINE FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA RS 2020-10-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212548-001 AA
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 2026-08-18 06:07:40 2026-07 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA RS 2020-10-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA RS 2020-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA RS 2020-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA RS 2020-10-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA RS 2020-10-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA RS 2020-10-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA RS 2020-10-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA RS 2020-10-06 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 2021-12-28 21:50 UTC 2021-12 A212548-001 CGT 2021-04-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212548-001 CGT 2021-04-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212548-001 CGT 2021-04-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212548-001 CGT 2021-04-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A212548-001 CGT 2021-04-04 c0c555d07b60…
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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50090-5826 FOSFOMYCIN TROMETHAMINE Granules for Oral A-S Medication Solutions ANDA Current 70700-268 FOSFOMYCIN TROMETHAMINE Granules for Oral Solution XIROMED LLC ANDA Current 70700-268 FOSFOMYCIN TROMETHAMINE Granules for Oral Solution XIROMED LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 65506 ORIG 2020-12-07