Application 212903
- Type
- ANDA
- Sponsor
- ANNORA PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE | SODIUM SULFATE;POTASSIUM SULFATE;MAGNESIUM SULFATE | SOLUTION;ORAL | 17.5GM/BOT;3.13GM/BOT;1.6GM/BOT | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A212903-001 | 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 | 2024-10-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A212903-001 | 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 | 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 | A212903-001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION / ORAL | AA | 2024-10-18 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A212903-001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION / ORAL | AA | 2024-10-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212903-001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION / ORAL | AA | 2024-10-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212903-001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION / ORAL | AA | 2024-10-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212903-001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION / ORAL | AA | 2024-10-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212903-001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION / ORAL | AA | 2024-10-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212903-001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION / ORAL | AA | 2024-10-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212903-001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION / ORAL | AA | 2024-10-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212903-001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION / ORAL | AA | 2024-10-18 | 2680178bc6a6… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212903-001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION / ORAL | AA | 2024-10-18 | d8e5a09893c0… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212903-001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION / ORAL | AA | 2024-10-18 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A212903-001 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A212903-001 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A212903-001 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212903-001 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A212903-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212903-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212903-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212903-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212903-001 | AA | 1 | 2680178bc6a6… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212903-001 | AA | 1 | d8e5a09893c0… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212903-001 | AA | 1 | a50c72e98297… |
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.
| 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 | Camber Pharmaceuticals, Inc. | 315c377b-a634-45ea-9beb-c0f58dad551d | 2025-01-17 | Warnings, Adverse reactions | 212903 ANDA212903 |
| 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 | 212903 ANDA212903 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 68029 | ORIG | 2021-07-08 |