Application 213071
- Type
- ANDA
- Sponsor
- NIVAGEN PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CALCIUM GLUCONATE | CALCIUM GLUCONATE | SOLUTION;INTRAVENOUS | 1GM/10ML (100MG/ML) | No | No |
| 002 | CALCIUM GLUCONATE | CALCIUM GLUCONATE | SOLUTION;INTRAVENOUS | 5GM/50ML (100MG/ML) | No | No |
| 003 | CALCIUM GLUCONATE | CALCIUM GLUCONATE | SOLUTION;INTRAVENOUS | 10GM/100ML (100MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213071-001 | CALCIUM GLUCONATE | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-10-14 | |
| A213071-002 | CALCIUM GLUCONATE | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-19 | |
| A213071-003 | CALCIUM GLUCONATE | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A213071-001 | AP |
| A213071-002 | AP |
| A213071-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A213071-001 | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-10-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A213071-002 | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A213071-003 | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213071-001 | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-10-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213071-002 | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213071-003 | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213071-001 | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-10-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213071-002 | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213071-003 | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213071-001 | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-10-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213071-002 | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213071-003 | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213071-001 | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-10-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213071-002 | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213071-003 | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213071-001 | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-10-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213071-002 | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213071-003 | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213071-001 | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-10-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213071-002 | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213071-003 | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213071-001 | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-10-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213071-002 | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213071-003 | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213071-001 | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-10-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213071-002 | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213071-003 | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213071-001 | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-10-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213071-002 | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213071-003 | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213071-001 | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-10-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213071-002 | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213071-003 | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213071-001 | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-10-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213071-002 | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213071-003 | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213071-001 | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-10-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213071-002 | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-19 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213071-003 | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213071-001 | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-10-14 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A213071-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A213071-002 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A213071-003 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A213071-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213071-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213071-003 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213071-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213071-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213071-003 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A213071-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213071-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213071-003 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213071-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213071-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213071-003 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213071-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213071-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213071-003 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213071-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213071-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213071-003 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213071-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213071-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213071-003 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213071-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213071-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213071-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213071-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213071-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213071-003 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A213071-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213071-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213071-003 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213071-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213071-002 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213071-003 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213071-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213071-002 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213071-003 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213071-001 | AP | 1 | 1e350fbaab3a… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2023-12-20 04:57 UTC | 2023-12 | A213071-001 | CGT | 2023-05-05 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A213071-001 | CGT | 2023-05-05 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A213071-001 | CGT | 2023-05-05 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A213071-001 | CGT | 2023-05-05 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A213071-001 | CGT | 2023-05-05 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A213071-001 | CGT | 2023-05-05 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A213071-001 | CGT | 2023-05-05 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A213071-001 | CGT | 2023-05-05 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| Calcium Gluconate | CALCIUM GLUCONATE | Henry Schein, Inc. | 3cbf6bf7-2415-4435-b3df-41855514a05d | 2025-12-23 | Warnings, Adverse reactions | 213071 ANDA213071 |
| calcium gluconate | CALCIUM GLUCONATE | REMEDYREPACK INC. | d6db3a1c-ed02-48fc-9134-ea1d58acf42e | 2025-06-12 | Warnings, Adverse reactions | 213071 ANDA213071 |
| calcium gluconate | CALCIUM GLUCONATE | Hikma Pharmaceuticals USA Inc. | 8ec4d137-1e9b-40e2-aeb2-8f62626a8fa5 | 2023-09-01 | Warnings, Adverse reactions | 213071 ANDA213071 |
| calcium gluconate | CALCIUM GLUCONATE | Hikma Pharmaceuticals USA Inc. | ce7becd8-cf59-4470-aac8-82761a24ebd7 | 2023-09-01 | Warnings, Adverse reactions | 213071 ANDA213071 |
| calcium gluconate | CALCIUM GLUCONATE | Hikma Pharmaceuticals USA Inc. | 313a4ea9-178b-495e-9bc7-af1860fa6501 | 2023-05-26 | Warnings, Adverse reactions | 213071 ANDA213071 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 75834-171 | calcium gluconate | calcium gluconate | Nivagen Pharmaceuticals, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 72946 | ORIG | 2022-12-20 |