Application 217624
- Type
- ANDA
- Sponsor
- STIRA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZINC SULFATE | ZINC SULFATE | SOLUTION;INTRAVENOUS | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | No | No |
| 002 | ZINC SULFATE | ZINC SULFATE | SOLUTION;INTRAVENOUS | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | No | No |
| 003 | ZINC SULFATE | ZINC SULFATE | SOLUTION;INTRAVENOUS | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217624-001 | ZINC SULFATE | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2025-06-10 | |
| A217624-002 | ZINC SULFATE | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2025-06-10 | |
| A217624-003 | ZINC SULFATE | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2025-06-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A217624-001 | AP |
| A217624-002 | AP |
| A217624-003 | AP |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A217624-001 | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2025-06-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217624-002 | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2025-06-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217624-003 | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2025-06-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217624-001 | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2025-06-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217624-002 | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2025-06-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217624-003 | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2025-06-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217624-001 | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2025-06-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217624-002 | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2025-06-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217624-003 | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2025-06-10 | 6a471c1ec25d… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217624-001 | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2025-06-10 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217624-002 | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2025-06-10 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217624-003 | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2025-06-10 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A217624-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217624-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217624-003 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217624-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217624-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217624-003 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A217624-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217624-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217624-003 | AP | 1 | 6a471c1ec25d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217624-001 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217624-002 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217624-003 | AP | 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 |
|---|---|---|---|---|---|---|
| ZINC SULFATE | ZINC SULFATE | Camber Pharmaceuticals, Inc. | 49698d00-f44b-4b1f-ae34-6b9067911757 | 2026-03-04 | Warnings, Adverse reactions | ZINC SULFATE ZINC SULFATE |
| Zinc Sulfate | ZINC SULFATE | Piramal Critical Care Inc. | dfa8a859-c285-17a3-e053-2a95a90a9343 | 2025-10-07 | Warnings, Adverse reactions | Zinc Sulfate ZINC SULFATE |
| Zinc Sulfate | ZINC SULFATE INJECTION | Apotex Corp | b9cf2dab-6ec8-e099-464a-af46a3601971 | 2025-01-16 | Warnings, Adverse reactions | Zinc Sulfate |
| Zinc Sulfate | ZINC SULFATE | Piramal Critical Care Inc. | 0b6078d9-624c-e162-e063-6394a90a147d | 2024-12-17 | Warnings, Adverse reactions | Zinc Sulfate ZINC SULFATE |
| zinc sulfate | ZINC SULFATE INJECTION, | Zydus Pharmaceuticals USA Inc. | 95aa8437-10bc-4205-939f-d21d8fa52a00 | 2024-12-06 | Warnings, Adverse reactions | zinc sulfate |
| Zinc sulfate | ZINC SULFATE | Somerset Therapeutics, LLC | c9d45d0e-a165-4112-81f9-c0e455572ecf | 2024-07-18 | Warnings, Adverse reactions | Zinc sulfate ZINC SULFATE |
| Zinc Sulfate | ZINC SULFATE | Gland Pharma Limited | 8f354f0a-4e10-4e4e-b86c-49d97cbd631d | 2023-09-07 | Warnings, Adverse reactions | Zinc Sulfate ZINC SULFATE |
| zinc sulfate | ZINC SULFATE | Zydus Lifesciences Limited | 74d8d07b-cfd9-4262-b689-fea12673bbd1 | 2023-08-31 | zinc sulfate ZINC SULFATE | |
| Zinc Sulfate | ZINC SULFATE | Fresenius Kabi USA, LLC | 37d54dcd-b720-4168-bfb2-c8f381466aac | 2023-01-04 | Warnings, Adverse reactions | Zinc Sulfate ZINC SULFATE |
| Zinc Sulfate | ZINC SULFATE | American Regent, Inc. | 4b528c88-07a0-4dce-84c6-ccd32555bbff | 2020-10-01 | Warnings, Adverse reactions | Zinc Sulfate ZINC SULFATE |