Home Applications 201850 Application 201850
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
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A201850-001 SODIUM CHLORIDE 0.9% SODIUM CHLORIDE 90MG/10ML (9MG/ML) SOLUTION / INJECTION 2012-01-20
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 · 43 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 2026-09-14 22:38:34 2026-08 A201850-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION 2012-01-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A201850-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION 2012-01-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201850-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION 2012-01-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201850-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION 2012-01-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201850-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION 2012-01-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201850-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION 2012-01-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201850-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION 2012-01-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201850-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION 2012-01-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201850-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION 2012-01-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201850-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION 2012-01-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201850-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION 2012-01-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201850-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION 2012-01-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201850-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION 2012-01-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201850-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION 2012-01-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201850-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION 2012-01-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201850-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION 2012-01-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201850-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION AP 2012-01-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201850-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION AP 2012-01-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201850-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION AP 2012-01-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201850-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION AP 2012-01-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201850-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION AP 2012-01-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201850-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION AP 2012-01-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201850-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION AP 2012-01-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201850-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION AP 2012-01-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201850-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION AP 2012-01-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201850-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION AP 2012-01-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201850-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION AP 2012-01-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201850-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION AP 2012-01-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201850-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION AP 2012-01-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201850-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2012-01-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201850-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2012-01-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201850-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2012-01-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201850-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2012-01-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201850-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2012-01-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201850-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2012-01-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201850-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION AP 2012-01-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201850-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION AP 2012-01-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201850-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION AP 2012-01-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201850-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION AP 2012-01-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201850-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION AP 2012-01-20 f41ea6bd6efb…
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 2 of 9 · 176 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye SODIUM CHLORIDE Hanlim 4ee80e16-1bb1-8238-e063-6294a90aa719 2026-04-04 Warnings Name fallback generic name: SODIUM CHLORIDE BACTERIOSTATIC SODIUM CHLORIDE SODIUM CHLORIDE Hospira, Inc. 376093e7-e09e-4a57-3199-195e45251866 2026-04-03 Boxed warning, Warnings, Adverse reactions Name fallback generic name: SODIUM CHLORIDE Sodium Chloride Normal Salt SODIUM CHLORIDE TWIN MED LLC 10230c8a-e5e5-44f1-b41d-80930899d6b9 2026-03-31 Warnings Name fallback generic name: SODIUM CHLORIDE Worafy Gentle Eye Wash SODIUM CHLORIDE Shenzhen Shandian Jingling Technology Co., Ltd. 4da864dc-e10c-1db9-e063-6394a90a0984 2026-03-22 Warnings Name fallback generic name: SODIUM CHLORIDE SODIUM CHLORIDE HYPERTONICITY SODIUM CHLORIDE YYBA CORP 439653b9-99b8-4799-8d67-4a2ada9c6783 2026-03-20 Warnings Name fallback generic name: SODIUM CHLORIDE Altachlore Sodium Chloride Hypertonicity Ophthalmic 5 Percent SODIUM CHLORIDE Altaire Pharmaceuticals Inc. e13fd053-9420-490c-a43e-e14b0930cb4e 2026-03-18 Warnings Name fallback generic name: SODIUM CHLORIDE RESP EASE SODIUM CHLORIDE Venture Healthcare Ltd 31b812c9-fb0a-5ee0-e063-6294a90a03e1 2026-03-16 Warnings Name fallback generic name: SODIUM CHLORIDE RESP EASE SODIUM CHLORIDE Venture Healthcare Ltd 31b88e7c-eca0-5540-e063-6294a90a1b18 2026-03-16 Warnings Name fallback generic name: SODIUM CHLORIDE RESP EASE SODIUM CHLORIDE Venture Healthcare Ltd 31b8c3f4-e528-c69d-e063-6294a90a5a34 2026-03-16 Warnings Name fallback generic name: SODIUM CHLORIDE RESP EASE SODIUM CHLORIDE Laboratoire Unither 31b7eb13-39c3-6f0e-e063-6394a90a4011 2026-03-16 Warnings Name fallback generic name: SODIUM CHLORIDE RESP EASE SODIUM CHLORIDE Laboratoire Unither 31b8bb9c-d30f-152f-e063-6394a90a5208 2026-03-16 Warnings Name fallback generic name: SODIUM CHLORIDE RESP EASE SODIUM CHLORIDE Laboratoire Unither 31b8dcbd-9e6b-1edc-e063-6394a90aac73 2026-03-16 Warnings Name fallback generic name: SODIUM CHLORIDE Sodium Chloride SODIUM CHLORIDE Hospira, Inc. 018a8807-1331-41c3-4889-c7ec502a9043 2026-03-09 Warnings, Adverse reactions Name fallback generic name: SODIUM CHLORIDE Oimmal Gentle Eye Wash SODIUM CHLORIDE Shenzhen Shandian Jingling Technology Co., Ltd. 4bb4e59b-a43e-fa38-e063-6294a90aea71 2026-02-26 Warnings Name fallback generic name: SODIUM CHLORIDE sodium chloride SODIUM CHLORIDE Medefil, Inc. d1468c0f-dd4f-4d38-a84c-c1d110303965 2026-02-26 Warnings, Adverse reactions Name fallback generic name: SODIUM CHLORIDE 0.9 percentsaline SODIUM CHLORIDE Huizhou Jinsheng Medical Technology Co., Ltd 487cb4fc-2e0b-020f-e063-6294a90a4526 2026-02-03 Warnings Name fallback generic name: SODIUM CHLORIDE 0.9saline SODIUM CHLORIDE Huizhou Jinsheng Medical Technology Co., Ltd 49e76aca-ca2b-3b95-e063-6394a90a875e 2026-02-03 Warnings Name fallback generic name: SODIUM CHLORIDE 0.9%saline SODIUM CHLORIDE Huizhou Jinsheng Medical Technology Co., Ltd 49e7b329-e4e5-6991-e063-6294a90ac817 2026-02-03 Warnings Name fallback generic name: SODIUM CHLORIDE Sodium Chloride SODIUM CHLORIDE Nephron Pharmaceuticals Corporation a4edf2d5-a9ff-30d4-e053-2995a90a5650 2026-01-26 Warnings, Adverse reactions Name fallback generic name: SODIUM CHLORIDE Sodium Chloride SODIUM CHLORIDE ProPharma Distribution 48d73434-e65b-dc98-e063-6294a90affa2 2026-01-20 Adverse reactions Name fallback generic name: SODIUM CHLORIDE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0641-1512 Sodium Chloride Sodium Chloride West-ward Pharmaceutical Corp. ANDA Current 0641-1512 Sodium Chloride Sodium Chloride Hikma Pharmaceuticals USA Inc. ANDA Current