Application 216249
- Type
- ANDA
- Sponsor
- GLAND PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZINC SULFATE | ZINC SULFATE | SOLUTION;INTRAVENOUS | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | No | No |
| 002 | ZINC SULFATE | ZINC SULFATE | SOLUTION;INTRAVENOUS | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | No | No |
| 003 | ZINC SULFATE | ZINC SULFATE | SOLUTION;INTRAVENOUS | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A216249-001 | ZINC SULFATE | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2022-05-03 | |
| A216249-002 | ZINC SULFATE | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2022-05-03 | |
| A216249-003 | ZINC SULFATE | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A216249-001 | AP |
| A216249-002 | AP |
| A216249-003 | 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 | A216249-001 | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2022-05-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216249-002 | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2022-05-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216249-003 | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216249-001 | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2022-05-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216249-002 | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2022-05-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216249-003 | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216249-001 | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2022-05-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216249-002 | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2022-05-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216249-003 | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216249-001 | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2022-05-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216249-002 | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2022-05-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216249-003 | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216249-001 | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2022-05-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216249-002 | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2022-05-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216249-003 | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216249-001 | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2022-05-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216249-002 | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2022-05-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216249-003 | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216249-001 | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2022-05-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216249-002 | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2022-05-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216249-003 | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216249-001 | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2022-05-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216249-002 | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2022-05-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216249-003 | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216249-001 | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2022-05-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216249-002 | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2022-05-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216249-003 | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216249-001 | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2022-05-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216249-002 | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2022-05-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216249-003 | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-01 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216249-001 | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2022-05-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216249-002 | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2022-05-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216249-003 | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-01 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216249-001 | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2022-05-03 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216249-002 | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2022-05-03 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216249-003 | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-01 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216249-001 | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2022-05-03 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216249-002 | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2022-05-03 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216249-003 | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-01 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A216249-001 | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2022-05-03 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A216249-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216249-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216249-003 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216249-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216249-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216249-003 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A216249-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216249-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216249-003 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216249-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216249-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216249-003 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216249-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216249-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216249-003 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216249-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216249-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216249-003 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216249-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216249-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216249-003 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216249-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216249-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216249-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216249-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216249-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216249-003 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A216249-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A216249-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A216249-003 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216249-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216249-002 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216249-003 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216249-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216249-002 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216249-003 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216249-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216249-002 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216249-003 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A216249-001 | AP | 1 | 8072bd15b7f6… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2023-01-26 05:58 UTC | 2023-01 | A216249-001 | CGT | 2022-12-24 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A216249-002 | CGT | 2022-12-24 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A216249-001 | CGT | 2022-12-24 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A216249-002 | CGT | 2022-12-24 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A216249-001 | CGT | 2022-12-24 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A216249-002 | CGT | 2022-12-24 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A216249-001 | CGT | 2022-12-24 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A216249-002 | CGT | 2022-12-24 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A216249-001 | CGT | 2022-12-24 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A216249-002 | CGT | 2022-12-24 | cb3db0bc1861… |
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 | Piramal Critical Care Inc. | dfa8a859-c285-17a3-e053-2a95a90a9343 | 2025-10-07 | Warnings, Adverse reactions | 216249 ANDA216249 66794-239 66794-240 |
| Zinc Sulfate | ZINC SULFATE | Piramal Critical Care Inc. | 0b6078d9-624c-e162-e063-6394a90a147d | 2024-12-17 | Warnings, Adverse reactions | 216249 ANDA216249 |
| Zinc Sulfate | ZINC SULFATE | Gland Pharma Limited | 8f354f0a-4e10-4e4e-b86c-49d97cbd631d | 2023-09-07 | Warnings, Adverse reactions | 216249 ANDA216249 68083-499 68083-498 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 66794-239 | Zinc Sulfate | Zinc Sulfate | Piramal Critical Care Inc. | ANDA | Current |
| 66794-239 | Zinc Sulfate | Zinc Sulfate | Piramal Critical Care Inc. | ANDA | Current |
| 66794-240 | Zinc Sulfate | Zinc Sulfate | Piramal Critical Care Inc. | ANDA | Current |
| 66794-240 | Zinc Sulfate | Zinc Sulfate | Piramal Critical Care Inc. | ANDA | Current |
| 68083-498 | Zinc Sulfate | Zinc Sulfate | Gland Pharma Limited | ANDA | Current |
| 68083-499 | Zinc Sulfate | Zinc Sulfate | Gland Pharma Limited | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 71886 | ORIG | 2022-08-25 |