Application 080855
- Type
- ANDA
- Sponsor
- LILLY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BETALIN 12 | CYANOCOBALAMIN | INJECTABLE;INJECTION | 0.1MG/ML | No | No |
| 002 | BETALIN 12 | CYANOCOBALAMIN | INJECTABLE;INJECTION | 1MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A080855-001 | BETALIN 12 | CYANOCOBALAMIN | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| A080855-002 | BETALIN 12 | CYANOCOBALAMIN | 1MG/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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A080855-001 | BETALIN 12 | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A080855-002 | BETALIN 12 | 1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A080855-001 | BETALIN 12 | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A080855-002 | BETALIN 12 | 1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A080855-001 | BETALIN 12 | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A080855-002 | BETALIN 12 | 1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080855-001 | BETALIN 12 | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080855-002 | BETALIN 12 | 1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A080855-001 | BETALIN 12 | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A080855-002 | BETALIN 12 | 1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080855-001 | BETALIN 12 | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080855-002 | BETALIN 12 | 1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080855-001 | BETALIN 12 | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080855-002 | BETALIN 12 | 1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080855-001 | BETALIN 12 | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080855-002 | BETALIN 12 | 1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080855-001 | BETALIN 12 | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080855-002 | BETALIN 12 | 1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080855-001 | BETALIN 12 | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080855-002 | BETALIN 12 | 1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080855-001 | BETALIN 12 | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080855-002 | BETALIN 12 | 1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A080855-001 | BETALIN 12 | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A080855-002 | BETALIN 12 | 1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080855-001 | BETALIN 12 | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080855-002 | BETALIN 12 | 1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080855-001 | BETALIN 12 | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080855-002 | BETALIN 12 | 1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080855-001 | BETALIN 12 | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080855-002 | BETALIN 12 | 1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A080855-001 | BETALIN 12 | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A080855-002 | BETALIN 12 | 1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A080855-001 | BETALIN 12 | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A080855-002 | BETALIN 12 | 1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A080855-001 | BETALIN 12 | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A080855-002 | BETALIN 12 | 1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A080855-001 | BETALIN 12 | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A080855-002 | BETALIN 12 | 1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A080855-001 | BETALIN 12 | 0.1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A080855-002 | BETALIN 12 | 1MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 74a2ff9319b5… |
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 | 15c4de10-c059-8c2f-e063-6394a90a03a3 | 2024-04-10 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| Nascobal | CYANOCOBALAMIN | Par Health USA, LLC | 697e0e52-c01b-4b53-9994-f79c46eb6b4f | 2024-03-01 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| CYANOCOBALAMIN | CYANOCOBALAMIN | HF Acquisition Co LLC, DBA HealthFirst | 953aa8c6-31ce-0c3b-e053-2a95a90ab35f | 2024-01-30 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| Cyanocobalamin | CYANOCOBALAMIN | Hikma Pharmaceuticals USA Inc. | a66eb3c4-3e1d-4d49-b963-4fa2334cc9b6 | 2023-12-01 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| Cyanocobalamin | CYANOCOBALAMIN | American Regent, Inc. | 2fb653d6-e2b2-4969-831b-c0dc37b9c0cc | 2023-10-31 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| Cyanocobalamin | CYANOCOBALAMIN | Asclemed USA, Inc. | 071f7c95-7243-4014-b336-db8962ac0f75 | 2023-10-03 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| Cyanocobalamin | CYANOCOBALAMIN | Lupin Pharmaceuticals,Inc. | efb7dc02-f0c9-4537-9e23-b641c428068c | 2023-08-24 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| Cyanocobalamin | CYANOCOBALAMIN | BluePoint Laboratories | cdd4fd12-e214-43a6-b560-d56fc0d87190 | 2023-05-05 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| cyanocobalamin | CYANOCOBALAMIN | Padagis Israel Pharmaceuticals Ltd | 971e5f30-55c2-4193-9dd8-b43a1862b92a | 2023-02-28 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| Cyanocobalamin | CYANOCOBALAMIN | Sagent Pharmaceuticals | 7e10c47d-1036-47c1-a0ed-6929636366c2 | 2023-02-15 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| Cyanocobalamin | CYANOCOBALAMIN | Gland Pharma Limited | cd8d188a-fa5d-4580-bcb1-ac8617118cbb | 2022-11-02 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| cyanocobalamin | CYANOCOBALAMIN | Asclemed USA, Inc. | d589cc00-a896-4a6b-b93c-a049c8af6973 | 2022-10-12 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| Cyanocobalamin | CYANOCOBALAMIN | Meitheal Pharmaceuticals Inc. | ccf5b124-083d-4465-a666-c1bc6e84d630 | 2022-04-29 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| cyanocobalamin | CYANOCOBALAMIN | Zydus Pharmaceuticals USA Inc. | e6712877-ace0-441c-99a9-adf567c0b9a2 | 2022-04-25 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| cyanocobalamin | CYANOCOBALAMIN | Zydus Lifesciences Limited | ef300a08-8212-40a9-847a-1b62348896dd | 2022-04-19 | CYANOCOBALAMIN | |
| Cyanocobalamin | CYANOCOBALAMIN | AuroMedics Pharma LLC | db84d0ea-5c15-47f5-bbe2-8d455e75695e | 2022-03-10 | Warnings, Adverse reactions | CYANOCOBALAMIN |
| Cyanocobalamin | CYANOCOBALAMIN | Asclemed USA, Inc. | 66e3441f-79fa-4a1b-be22-2bc683cd7abc | 2021-07-08 | Warnings, Adverse reactions | CYANOCOBALAMIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.