Application 218840
- Type
- ANDA
- Sponsor
- CAPLIN
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 |
|---|---|---|---|---|---|---|---|
| A218840-001 | CALCIUM GLUCONATE | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2026-05-04 | |
| A218840-002 | CALCIUM GLUCONATE | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2026-05-04 | |
| A218840-003 | CALCIUM GLUCONATE | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2026-05-04 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A218840-001 | AP |
| A218840-002 | AP |
| A218840-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218840-001 | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2026-05-04 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218840-002 | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2026-05-04 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218840-003 | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | 2026-05-04 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218840-001 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218840-002 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218840-003 | 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 |
|---|---|---|---|---|---|---|
| Calcium Gluconate | CALCIUM GLUCONATE | GLENMARK PHARMACEUTICALS INC., USA | b2470072-f443-4596-ae33-1b8b0d05bc9d | 2026-06-11 | Warnings, Adverse reactions | 218840 ANDA218840 |
| Calcium Gluconate | CALCIUM GLUCONATE | Caplin Steriles Limited | f28e9871-d546-4b48-ac3d-aead0d4c0449 | 2026-05-13 | Warnings, Adverse reactions | 218840 ANDA218840 |