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 8 of 9 · 176 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Nat Mur SODIUM CHLORIDE Hyland's Inc. d3ab4254-daaf-24ac-e053-2995a90afb8f 2022-12-13 Warnings Name fallback generic name: SODIUM CHLORIDE Sodium Chloride SODIUM CHLORIDE Baxter Healthcare Corporation 2fae04e3-20b1-4b8c-b1fb-646b384836f1 2022-12-07 Warnings, Adverse reactions Name fallback generic name: SODIUM CHLORIDE Sodium Chloride SODIUM CHLORIDE Fresenius Kabi USA, LLC 51da05ce-e3c4-4ef5-a845-dc869152e17f 2022-10-24 Warnings, Adverse reactions Name fallback generic name: SODIUM CHLORIDE Sterile Saline Kids Mist PediaMeds SODIUM CHLORIDE ASCENT CONSUMER PRODUCTS, INC. e5c5b580-1d9f-3081-e053-2995a90a8031 2022-08-08 Warnings Name fallback generic name: SODIUM CHLORIDE Sterile Saline Kids Mist SinuCleanse Breathe SODIUM CHLORIDE ASCENT CONSUMER PRODUCTS, INC. e5c5c313-046f-b0a7-e053-2a95a90a2a07 2022-08-08 Warnings Name fallback generic name: SODIUM CHLORIDE SODIUM CHLORIDE SODIUM CHLORIDE Baxter Healthcare Corporation 123bd10a-90c7-499e-97f6-acf7e0f0fb4e 2022-07-29 Warnings, Adverse reactions Name fallback generic name: SODIUM CHLORIDE Natrium Muriaticum 6X SODIUM CHLORIDE Seroyal USA 0ebf18de-12fe-0bc4-e054-00144ff88e88 2022-07-07 Warnings Name fallback generic name: SODIUM CHLORIDE Sodium Chloride SODIUM CHLORIDE B. Braun Medical Inc. 24a08a93-df23-474b-873e-c59ec8855f9f 2022-03-14 Warnings, Adverse reactions Name fallback generic name: SODIUM CHLORIDE Wild Horse 777 Moisturizing Nasal SODIUM CHLORIDE Wild Horse 777, Inc. b0b4dadd-11fa-3dbb-e053-2995a90a2097 2022-03-14 Warnings Name fallback generic name: SODIUM CHLORIDE Sodium Chloride SODIUM CHLORIDE B. Braun Medical Inc. cc14fafd-3dcd-4fc8-bdbd-6f355c375768 2022-02-23 Warnings, Adverse reactions Name fallback generic name: SODIUM CHLORIDE Sodium Chloride SODIUM CHLORIDE Fresenius Kabi USA, LLC 8b44bfd3-70a4-4b47-bc7b-590f63b8cc75 2022-02-15 Warnings, Adverse reactions Name fallback generic name: SODIUM CHLORIDE Sodium Chloride SODIUM CHLORIDE Fresenius Kabi USA, LLC f62481fd-fcdb-4be6-ac13-29c590e925c3 2022-02-10 Adverse reactions Name fallback generic name: SODIUM CHLORIDE Sodium Chloride SODIUM CHLORIDE B. Braun Medical Inc. e44c41ae-c9c8-4dd8-ba6c-cebb585378aa 2022-01-31 Warnings, Adverse reactions Name fallback generic name: SODIUM CHLORIDE Sterile Saline Mist Walgreens SODIUM CHLORIDE WALGREEN COMPANY d6b9d4fc-b758-be32-e053-2995a90a2523 2022-01-29 Warnings Name fallback generic name: SODIUM CHLORIDE Extra Strenght Saline Mist Rite Aid SODIUM CHLORIDE RITE AID CORPORATION d5b30fb2-4052-4a0c-e053-2a95a90aacd5 2022-01-16 Warnings Name fallback generic name: SODIUM CHLORIDE Sterile Saline Mist Rite Aid SODIUM CHLORIDE RITE AID d583067e-1133-7d7d-e053-2a95a90a1e36 2022-01-13 Warnings Name fallback generic name: SODIUM CHLORIDE SinuCleanse Sterile Saline Mist SODIUM CHLORIDE ASCENT CONSUMER PRODUCTS, INC 648da2bc-bc91-4295-9e46-d3055cdc2418 2022-01-08 Warnings Name fallback generic name: SODIUM CHLORIDE SinuCleanse Nasal Drip SODIUM CHLORIDE ASCENT CONSUMER PRODUCTS, INC d5129a91-50e7-6b94-e053-2a95a90a2b30 2022-01-08 Warnings Name fallback generic name: SODIUM CHLORIDE SinuCleanse Sterile Saline Mist Daily Care SODIUM CHLORIDE ASCENT CONSUMER PRODUCTS, INC d5131ab2-8213-3659-e053-2a95a90ab2ab 2022-01-08 Warnings Name fallback generic name: SODIUM CHLORIDE Sodium Chloride SODIUM CHLORIDE Fresenius Kabi USA, LLC 4829ee40-c2d7-4e17-a606-75e8a8628413 2021-12-21 Warnings, 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