Home Applications 216920 Application 216920
Type ANDA
Sponsor HIKMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SODIUM ACETATE SODIUM ACETATE SOLUTION;INTRAVENOUS 40MEQ/20ML (2MEQ/ML) No No 002 SODIUM ACETATE SODIUM ACETATE SOLUTION;INTRAVENOUS 100MEQ/50ML (2MEQ/ML) No No 003 SODIUM ACETATE SODIUM ACETATE SOLUTION;INTRAVENOUS 200MEQ/100ML (2MEQ/ML) No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216920-001 SODIUM ACETATE SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 A216920-002 SODIUM ACETATE SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 A216920-003 SODIUM ACETATE SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 2 · 45 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 A216920-001 SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216920-002 SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216920-003 SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216920-001 SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216920-002 SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216920-003 SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216920-001 SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216920-002 SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216920-003 SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216920-001 SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216920-002 SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216920-003 SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216920-001 SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216920-002 SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216920-003 SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216920-001 SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216920-002 SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216920-003 SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216920-001 SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216920-002 SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216920-003 SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216920-001 SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216920-002 SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216920-003 SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216920-001 SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216920-002 SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216920-003 SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216920-001 SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216920-002 SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216920-003 SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216920-001 SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216920-002 SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216920-003 SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216920-001 SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216920-002 SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216920-003 SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216920-001 SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216920-002 SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216920-003 SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216920-001 SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 45 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216920-001 CGT 2024-11-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216920-001 CGT 2024-11-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216920-001 CGT 2024-11-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216920-001 CGT 2024-11-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216920-001 CGT 2024-11-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216920-001 CGT 2024-11-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216920-001 CGT 2024-11-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216920-001 CGT 2024-11-16 1e350fbaab3a…
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.