Home Applications 077407 Application 077407
Type ANDA
Sponsor TARO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 9MG/ML No Yes 002 SODIUM CHLORIDE SODIUM CHLORIDE INJECTABLE; INJECTION 10ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A077407-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 45MG/5ML (9MG/ML) SOLUTION / INJECTION AP RS 2006-08-11 A077407-002 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP RS 2006-08-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2 of 2 · 68 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 2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077407-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 9MG/ML INJECTABLE / INJECTION AP RS 2006-08-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077407-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 9MG/ML INJECTABLE / INJECTION AP RS 2006-08-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077407-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 9MG/ML INJECTABLE / INJECTION AP RS 2006-08-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077407-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 9MG/ML INJECTABLE / INJECTION AP RS 2006-08-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077407-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 9MG/ML INJECTABLE / INJECTION AP RS 2006-08-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077407-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 9MG/ML INJECTABLE / INJECTION AP RS 2006-08-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077407-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 9MG/ML INJECTABLE / INJECTION AP RS 2006-08-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077407-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 45MG/5ML (9MG/ML) SOLUTION / INJECTION AP RS 2006-08-11 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077407-002 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP RS 2006-08-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077407-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 45MG/5ML (9MG/ML) SOLUTION / INJECTION AP RS 2006-08-11 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A077407-002 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP RS 2006-08-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077407-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 45MG/5ML (9MG/ML) SOLUTION / INJECTION AP RS 2006-08-11 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A077407-002 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP RS 2006-08-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077407-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 45MG/5ML (9MG/ML) SOLUTION / INJECTION AP RS 2006-08-11 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077407-002 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP RS 2006-08-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077407-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 45MG/5ML (9MG/ML) SOLUTION / INJECTION AP RS 2006-08-11 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077407-002 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP RS 2006-08-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077407-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 45MG/5ML (9MG/ML) SOLUTION / INJECTION AP RS 2006-08-11 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077407-002 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP RS 2006-08-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077407-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 9MG/ML INJECTABLE / INJECTION AP RS 2006-08-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077407-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 9MG/ML INJECTABLE / INJECTION AP RS 2006-08-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077407-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 9MG/ML INJECTABLE / INJECTION AP RS 2006-08-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077407-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 9MG/ML INJECTABLE / INJECTION AP RS 2006-08-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077407-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 9MG/ML INJECTABLE / INJECTION AP RS 2006-08-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077407-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 9MG/ML INJECTABLE / INJECTION AP RS 2006-08-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077407-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 9MG/ML INJECTABLE / INJECTION AP RS 2006-08-11 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A077407-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 45MG/5ML (9MG/ML) SOLUTION / INJECTION AP RS 2006-08-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A077407-002 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP RS 2006-08-11 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 observed states.
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 9 · 174 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Nacl 0.9% Normal Saline Solution SODIUM CHLORIDE CHI FUNG TECHNOLOGY COMPANY 5a53c4c8-c9de-700c-e063-6394a90a3ab5 2026-08-31 Warnings Name fallback generic name: SODIUM CHLORIDE Sodium Chloride SODIUM CHLORIDE YYBA CORP 597f3347-647c-3545-e063-6294a90abab2 2026-08-20 Warnings Name fallback generic name: SODIUM CHLORIDE Sodium Chloride SODIUM CHLORIDE Fresenius Kabi USA, LLC 2e5fe9f4-78e5-4af4-8bf9-9680e5dc5e88 2026-08-20 Warnings, Adverse reactions Name fallback generic name: SODIUM CHLORIDE Hypertonic Saline SODIUM CHLORIDE NAVEH PHARMA (1996) LTD 167c7a9c-1228-4fb2-a89c-d3e148386323 2026-07-30 Warnings Name fallback generic name: SODIUM CHLORIDE Hypertonic Saline Solution Sodium Chloride SODIUM CHLORIDE NAVEH PHARMA (1996) LTD 750ea4b1-de2b-4299-aaa2-331daf383d0d 2026-07-30 Warnings Name fallback generic name: SODIUM CHLORIDE Sodium Chloride SODIUM CHLORIDE Fresenius Medical Care de Mexico, S.A. de C.V. 9a1220fb-6853-45ae-838c-10d8596e1af7 2026-07-27 Warnings, Adverse reactions Name fallback generic name: SODIUM CHLORIDE Sodium Chloride SODIUM CHLORIDE Fresenius Medical Care Renal Therapies Group, LLC af5cdf1a-19f4-11e2-892e-0800200c9a66 2026-07-27 Warnings, Adverse reactions Name fallback generic name: SODIUM CHLORIDE Sodium Chloride SODIUM CHLORIDE LABORATORIOS GRIFOLS SA eb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf 2026-07-15 Warnings, Adverse reactions Name fallback generic name: SODIUM CHLORIDE WHWSWB 0.9% Saline SODIUM CHLORIDE Yiwu Huanshu E-commerce Co., Ltd 4e9c21e5-f2f9-90e4-e063-6394a90acfe2 2026-07-11 Warnings Name fallback generic name: SODIUM CHLORIDE WHWSWB 0.9% SALINE SODIUM CHLORIDE Yiwu Huanshu E-commerce Co., Ltd 5082b773-79b2-2501-e063-6394a90a170f 2026-07-11 Warnings Name fallback generic name: SODIUM CHLORIDE SALINE NASAL SODIUM CHLORIDE ALAINA HEALTHCARE PRIVATE LIMITED ed30a7f9-7132-42da-9bed-63a9b1c80ab2 2026-07-07 Warnings Name fallback generic name: SODIUM CHLORIDE 0.9% Sodium Chloride Saline Solution SODIUM CHLORIDE Yunqi Cosmetics (Shenzhen) Co., Ltd 546af257-dbd1-11fc-e063-6394a90a8e0a 2026-06-16 Warnings Name fallback generic name: SODIUM CHLORIDE Sodium Chloride SODIUM CHLORIDE Cardinal Health 107, LLC 107af8bc-b6af-4b85-8c8a-ea757dcef1da 2026-06-12 Adverse reactions Name fallback generic name: SODIUM CHLORIDE SALINE CLEANING SODIUM CHLORIDE Guangzhou Huanmei Cosmetics Co., Ltd. 524f07cc-ddb9-dda5-e063-6394a90ac0a5 2026-05-21 Warnings Name fallback generic name: SODIUM CHLORIDE Sodium Chloride SODIUM CHLORIDE Hospira, Inc. a2a964f7-c3ec-4dfb-e3a0-6d8136a80397 2026-05-19 Warnings, Adverse reactions Name fallback generic name: SODIUM CHLORIDE Sodium Chloride SODIUM CHLORIDE Sportpharm LLC a2c111f6-74d5-4a5d-82ac-d0f237488cb8 2026-04-24 Warnings, Adverse reactions Name fallback generic name: SODIUM CHLORIDE Sodium Chloride SODIUM CHLORIDE Method Pharmaceuticals, LLC 4b08859e-65bd-8255-e063-6394a90af614 2026-04-23 Warnings Name fallback generic name: SODIUM CHLORIDE SODIUM CHLORIDE 1 GRAM SODIUM CHLORIDE Gendose Pharmaceuticals, LLC ce988ae5-61c6-4324-90e1-a94c8a54d0d0 2026-04-13 Warnings Name fallback generic name: SODIUM CHLORIDE Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye SODIUM CHLORIDE Walgreen Company bda3b9db-5fc4-408c-a5ae-d1eeb3ee308d 2026-04-06 Warnings Name fallback generic name: SODIUM CHLORIDE 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
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 43120 ORIG 2011-12-14