Application 010791
- Type
- NDA
- Sponsor
- BEL MAR
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RUBIVITE | CYANOCOBALAMIN | INJECTABLE;INJECTION | 0.05MG/ML | No | No |
| 002 | RUBIVITE | CYANOCOBALAMIN | INJECTABLE;INJECTION | 0.1MG/ML | No | No |
| 003 | RUBIVITE | CYANOCOBALAMIN | INJECTABLE;INJECTION | 1MG/ML | No | No |
| 004 | RUBIVITE | CYANOCOBALAMIN | INJECTABLE;INJECTION | 0.03MG/ML | No | No |
| 005 | RUBIVITE | CYANOCOBALAMIN | INJECTABLE;INJECTION | 0.12MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N010791-001 | RUBIVITE | CYANOCOBALAMIN | 0.05MG/ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| N010791-002 | RUBIVITE | CYANOCOBALAMIN | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| N010791-003 | RUBIVITE | CYANOCOBALAMIN | 1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| N010791-004 | RUBIVITE | CYANOCOBALAMIN | 0.03MG/ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| N010791-005 | RUBIVITE | CYANOCOBALAMIN | 0.12MG/ML | INJECTABLE / INJECTION | Approved before 1982 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N010791-001 | RUBIVITE | 0.05MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N010791-002 | RUBIVITE | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N010791-003 | RUBIVITE | 1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N010791-004 | RUBIVITE | 0.03MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N010791-005 | RUBIVITE | 0.12MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N010791-001 | RUBIVITE | 0.05MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N010791-002 | RUBIVITE | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N010791-003 | RUBIVITE | 1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N010791-004 | RUBIVITE | 0.03MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N010791-005 | RUBIVITE | 0.12MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010791-001 | RUBIVITE | 0.05MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010791-002 | RUBIVITE | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010791-003 | RUBIVITE | 1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010791-004 | RUBIVITE | 0.03MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010791-005 | RUBIVITE | 0.12MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010791-001 | RUBIVITE | 0.05MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010791-002 | RUBIVITE | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010791-003 | RUBIVITE | 1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010791-004 | RUBIVITE | 0.03MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010791-005 | RUBIVITE | 0.12MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N010791-001 | RUBIVITE | 0.05MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N010791-002 | RUBIVITE | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N010791-003 | RUBIVITE | 1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N010791-004 | RUBIVITE | 0.03MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N010791-005 | RUBIVITE | 0.12MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N010791-001 | RUBIVITE | 0.05MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N010791-002 | RUBIVITE | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N010791-003 | RUBIVITE | 1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N010791-004 | RUBIVITE | 0.03MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N010791-005 | RUBIVITE | 0.12MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N010791-001 | RUBIVITE | 0.05MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N010791-002 | RUBIVITE | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N010791-003 | RUBIVITE | 1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N010791-004 | RUBIVITE | 0.03MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N010791-005 | RUBIVITE | 0.12MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N010791-001 | RUBIVITE | 0.05MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N010791-002 | RUBIVITE | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N010791-003 | RUBIVITE | 1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N010791-004 | RUBIVITE | 0.03MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N010791-005 | RUBIVITE | 0.12MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 1e350fbaab3a… |
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 |
|---|---|---|---|---|---|---|
| CYANOCOBALAMIN | CYANOCOBALAMIN | HF Acquisition Co LLC, DBA HealthFirst | 54f088b1-7cf8-3837-e063-6294a90a88e7 | 2026-09-02 | Adverse reactions | CYANOCOBALAMIN |
| Cyanocobalamin | CYANOCOBALAMIN | Lifestar Pharma LLC | b1e35c97-2157-454e-967f-53a4300827de | 2026-08-06 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| Cyanocobalamin | CYANOCOBALAMIN | NorthStar RxLLC | ce0183b3-4410-466a-b57d-cd360d461b7c | 2026-08-06 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| Non-proprietary name | CYANOCOBALAMIN | Xseer Pharmaceuticals | 3bb870d8-128d-75ea-e063-6394a90a707b | 2026-05-13 | CYANOCOBALAMIN | |
| Cyanocobalamin | CYANOCOBALAMIN | Plano Pharmaceuticals Inc. | 4cbc05f6-4b31-4a5f-e063-6394a90a676c | 2026-03-25 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| cyanocobalamin | CYANOCOBALAMIN | Sportpharm LLC | 647842f4-b211-4f52-8b73-975fae767023 | 2026-02-05 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| Cyanocobalamin | CYANOCOBALAMIN | A-S Medication Solutions | a61181f5-7e2d-45f9-929a-cb8bc70c992e | 2026-01-06 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| Cyanocobalamin | CYANOCOBALAMIN | SOLA Pharmaceuticals | e559c6c8-2973-77fb-e053-2995a90af43d | 2025-12-08 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| Cyanocobalamin | CYANOCOBALAMIN | BluePoint Laboratories | 5c603ad0-9023-44cc-955c-3988d5dcf0d3 | 2025-12-05 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| CYANOCOBALAMIN | CYANOCOBALAMIN | Henry Schein, Inc. | ff32f34b-89b3-4617-ad42-2e8bcb88627e | 2025-10-16 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| Cyanocobalamin | CYANOCOBALAMIN | Henry Schein, Inc. | 92f08572-cfd9-4a99-bb49-937ab94eeb62 | 2025-09-10 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| cyanocobalamin | CYANOCOBALAMIN | Somerset Therapeutics, LLC | 41ac0dc1-0a71-4c69-8e25-ba838f5f16a3 | 2025-09-04 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| CYANOCOBALAMIN | CYANOCOBALAMIN | Somerset Therapeutics, LLC | 617e44f8-df80-4764-85b9-be0fb6da8db3 | 2025-08-29 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| Cyanocobalamin | CYANOCOBALAMIN | Meitheal Pharmaceuticals Inc. | 064c6841-3ed2-417f-a77c-a730785b6036 | 2025-06-12 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| CYANOCOBALAMIN | CYANOCOBALAMIN | HF Acquisition Co LLC, DBA HealthFirst | 9d4ac337-5f4d-ef47-e053-2a95a90a6dbf | 2025-01-08 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| Cyanocobalamin | CYANOCOBALAMIN | Vitruvias Therapeutics | 2117af8a-723f-4e2f-98a6-83ad2c423751 | 2024-12-20 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| Cyanocobalamin | CYANOCOBALAMIN | Fresenius Kabi USA, LLC | acff4ff3-4435-4995-a117-dbfcdf72334a | 2024-12-15 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| Cyanocobalamin | CYANOCOBALAMIN | Fresenius Kabi USA, LLC | 8b1cdee5-3368-40e4-90bf-31a64df1f38a | 2024-12-12 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| Cyanocobalamin | CYANOCOBALAMIN | Meitheal Pharmaceuticals Inc. | 9c37fd25-2143-410c-8d89-d39aa5c7b453 | 2024-11-22 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| Cyanocobalamin | CYANOCOBALAMIN | Meitheal Pharmaceuticals Inc. | c6436212-9246-4e29-8540-9af992b667eb | 2024-06-03 | Warnings, Adverse reactions | CYANOCOBALAMIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.