Home Applications 209941 Application 209941
Type ANDA
Sponsor LANNETT CO INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE SOLUTION;ORAL 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A209941-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2024-07-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209941-001 AA
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.
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 A209941-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2024-07-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209941-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2024-07-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209941-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2024-07-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209941-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2024-07-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209941-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2024-07-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209941-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2024-07-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209941-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2024-07-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209941-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2024-07-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209941-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2024-07-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209941-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2024-07-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209941-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2024-07-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209941-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2024-07-15 79d66fd596c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209941-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2024-07-15 a50c72e98297…
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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE Ascend Laboratories, LLC 2106d1aa-086e-4248-9a3d-ec138d492cf3 2026-08-08 Warnings, Adverse reactions Name fallback brand name: Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE Wilshire Pharmaceuticals, Inc. f269929e-c2ff-4288-9d3b-7770bcb5a498 2026-04-13 Warnings, Adverse reactions Name fallback brand name: SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE Affordable Pharmaceuticals, LLC f86bdcc8-e643-4160-89ae-01c89bee842d 2025-11-30 Warnings, Adverse reactions Name fallback brand name: SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE Sodium sulfate, potassium sulfate and magnesium sulfate SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE Camber Pharmaceuticals, Inc. 315c377b-a634-45ea-9beb-c0f58dad551d 2025-01-17 Warnings, Adverse reactions Name fallback brand name: Sodium sulfate, potassium sulfate and magnesium sulfate Sodium sulfate, potassium sulfate and magnesium sulfate SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE NorthStar RxLLC ac46a219-4381-42fc-a931-ee469703e568 2025-01-17 Warnings, Adverse reactions Name fallback brand name: Sodium sulfate, potassium sulfate and magnesium sulfate
Documents# Document, Submission type, Date table Document Submission type Date 70088 ORIG 2022-02-04