Home Applications 201833 Application 201833
Type ANDA
Sponsor WEST-WARD PHARMS INT Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SODIUM CHLORIDE 0.9% SODIUM CHLORIDE INJECTABLE;INJECTION 9MG/ML No No 002 SODIUM CHLORIDE 0.9% SODIUM CHLORIDE SOLUTION;INJECTION 90MG/10ML (9MG/ML) No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A201833-001 SODIUM CHLORIDE 0.9% SODIUM CHLORIDE 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 A201833-002 SODIUM CHLORIDE 0.9% SODIUM CHLORIDE 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201833-002 AP
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 · 64 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 2026-08-18 06:07:40 2026-07 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201833-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION 2013-09-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201833-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION 2013-09-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201833-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION 2013-09-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201833-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION 2013-09-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201833-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION 2013-09-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201833-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION 2013-09-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201833-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION 2013-09-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201833-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION 2013-09-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201833-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION 2013-09-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201833-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION 2013-09-24 c0c555d07b60…
Observed Orange Book normalized TE history# 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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0641-0497 Sodium Chloride Sodium Chloride Hikma Pharmaceuticals USA Inc. ANDA Current 0641-0497 Sodium Chloride Sodium Chloride West-Ward Pharmaceuticals Corp. ANDA Current 0641-6144 Sodium Chloride Sodium Chloride Hikma Pharmaceuticals USA Inc. ANDA Current 0641-6144 Sodium Chloride Sodium Chloride West-Ward Pharmaceuticals Corp. ANDA Current