Application 219239
- Type
- ANDA
- Sponsor
- GLAND
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EPINEPHRINE | EPINEPHRINE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 10MG/10ML (1MG/ML) | No | No |
| 002 | EPINEPHRINE | EPINEPHRINE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 30MG/30ML (1MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A219239-001 | EPINEPHRINE | EPINEPHRINE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2025-02-06 | |
| A219239-002 | EPINEPHRINE | EPINEPHRINE | 30MG/30ML (1MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2025-10-02 | |
| A219239-003 | EPINEPHRINE | EPINEPHRINE | 1MG/ML (1MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2026-09-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A219239-001 | AP |
| A219239-002 | AP |
| A219239-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-11-14 07:37:17 | 2026-10 | A219239-001 | EPINEPHRINE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2025-02-06 | d4dbc9d85df4… | |
| 2026-11-14 07:37:17 | 2026-10 | A219239-002 | EPINEPHRINE | 30MG/30ML (1MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2025-10-02 | d4dbc9d85df4… | |
| 2026-11-14 07:37:17 | 2026-10 | A219239-003 | EPINEPHRINE | 1MG/ML (1MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2026-09-22 | d4dbc9d85df4… | |
| 2026-10-15 13:18:30 | 2026-09 | A219239-001 | EPINEPHRINE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2025-02-06 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A219239-002 | EPINEPHRINE | 30MG/30ML (1MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2025-10-02 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A219239-003 | EPINEPHRINE | 1MG/ML (1MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2026-09-22 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A219239-001 | EPINEPHRINE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2025-02-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A219239-002 | EPINEPHRINE | 30MG/30ML (1MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2025-10-02 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A219239-001 | EPINEPHRINE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2025-02-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A219239-002 | EPINEPHRINE | 30MG/30ML (1MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2025-10-02 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219239-001 | EPINEPHRINE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2025-02-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219239-002 | EPINEPHRINE | 30MG/30ML (1MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2025-10-02 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219239-001 | EPINEPHRINE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2025-02-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219239-002 | EPINEPHRINE | 30MG/30ML (1MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2025-10-02 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A219239-001 | EPINEPHRINE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2025-02-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A219239-001 | EPINEPHRINE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAOCULAR, SUBCUTANEOUS | AP | 2025-02-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A219239-001 | EPINEPHRINE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAOCULAR, SUBCUTANEOUS | AP | 2025-02-06 | b8a1b40f171c… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219239-001 | EPINEPHRINE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2025-02-06 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219239-002 | EPINEPHRINE | 30MG/30ML (1MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2025-10-02 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-11-14 07:37:17 | 2026-10 | A219239-001 | AP | 1 | d4dbc9d85df4… |
| 2026-11-14 07:37:17 | 2026-10 | A219239-002 | AP | 1 | d4dbc9d85df4… |
| 2026-11-14 07:37:17 | 2026-10 | A219239-003 | AP | 1 | d4dbc9d85df4… |
| 2026-10-15 13:18:30 | 2026-09 | A219239-001 | AP | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A219239-002 | AP | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A219239-003 | AP | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A219239-001 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A219239-002 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A219239-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A219239-002 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A219239-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A219239-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219239-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219239-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A219239-001 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A219239-001 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A219239-001 | AP | 1 | b8a1b40f171c… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219239-001 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219239-002 | AP | 1 | a50c72e98297… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219239-001 | CGT | 2025-09-03 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A219239-001 | CGT | 2025-09-03 | 6a471c1ec25d… |
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 |
|---|---|---|---|---|---|---|
| epinephrine | EPINEPHRINE | Gland Pharma Limited | b7b5e709-2125-4568-9a1d-9b4ea75d6c4a | 2025-06-03 | Warnings, Adverse reactions | epinephrine EPINEPHRINE |
| EPINEPHRINE | EPINEPHRINE | Amneal Pharmaceuticals Private Limited | 33fa2443-5c80-4967-98bb-f60d3144421c | 2025-05-14 | Warnings, Adverse reactions | EPINEPHRINE EPINEPHRINE |
| neffy | EPINEPHRINE | Medical Purchasing Solutions, LLC | 2d4063e8-f56c-6902-e063-6294a90a0d40 | 2025-02-03 | Warnings, Adverse reactions | EPINEPHRINE |
| Epinephrine Convenience Kit | EPINEPHRINE | HF Acquisition Co LLC, DBA HealthFirst | 9df23744-3b5b-5815-e053-2a95a90acc47 | 2025-01-08 | Warnings, Adverse reactions | EPINEPHRINE |
| Epinephrine | EPINEPHRINE | Advanced Rx Pharmacy of Tennessee, LLC | f4d7aca4-0acd-74c2-e053-2995a90a9d94 | 2024-12-31 | Warnings, Adverse reactions | Epinephrine EPINEPHRINE |
| Auvi-Q | EPINEPHRINE | Medical Purchasing Solutions, LLC | 296a9023-b5c6-6102-e063-6294a90af87e | 2024-12-16 | Warnings, Adverse reactions | EPINEPHRINE |
| Epinephrine | EPINEPHRINE | International Medication Systems, Limited | f2b5f15b-8541-466a-a27a-ee57bc4aac67 | 2024-12-16 | Warnings, Adverse reactions | Epinephrine EPINEPHRINE |
| Auvi-Q | EPINEPHRINE | Medical Purchasing Solutions, LLC | 29299266-69c5-b1a7-e063-6394a90a25f8 | 2024-12-13 | Warnings, Adverse reactions | EPINEPHRINE |
| Epinephrine | ADRENALINUM | Deseret Biologicals, Inc. | 89fefa8e-dbad-4150-858e-c14d1f31abbf | 2024-10-22 | Warnings | Epinephrine |
| epinephrine | EPINEPHRINE | Asclemed USA, Inc. | 0a29fe62-e241-4272-b91c-c1036b031cd4 | 2024-08-02 | Warnings, Adverse reactions | epinephrine EPINEPHRINE |
| Epinephrine | EPINEPHRINE | International Medication Systems, Limited | 7b6ffd77-8b25-4ff1-993e-dbfd7e0834cf | 2024-06-19 | Warnings, Adverse reactions | Epinephrine EPINEPHRINE |
| EPINEPHRINE | EPINEPHRINE | HF Acquisition Co LLC, DBA HealthFirst | 98aaa648-fc25-754d-e053-2995a90a7051 | 2024-03-08 | Warnings, Adverse reactions | EPINEPHRINE EPINEPHRINE |
| EPINEPHRINE | EPINEPHRINE | HF Acquisition Co LLC, DBA HealthFirst | 7664bb0d-dc1a-ca8b-e053-2991aa0ad627 | 2024-02-19 | Warnings, Adverse reactions | EPINEPHRINE EPINEPHRINE |
| EPINEPHRINE | EPINEPHRINE | HF Acquisition Co LLC, DBA HealthFirst | c0d1def8-9f47-0d3e-e053-2995a90af955 | 2024-01-30 | Warnings, Adverse reactions | EPINEPHRINE EPINEPHRINE |
| EPINEPHRINE | EPINEPHRINE | HF Acquisition Co LLC, DBA HealthFirst | f9c82678-5f4d-fded-e053-6394a90ac16d | 2024-01-22 | Warnings, Adverse reactions | EPINEPHRINE EPINEPHRINE |
| Epinephrine | EPINEPHRINE | Bryant Ranch Prepack | a7ae17f8-de81-4de9-a89f-bb930c6a27ec | 2024-01-15 | Warnings, Adverse reactions | Epinephrine EPINEPHRINE |
| Adrenalinum | EPINEPHRINE | Boiron | 83fa46ed-ce86-5054-e053-2991aa0ab381 | 2023-12-21 | EPINEPHRINE | |
| Epinephrine | EPINEPHRINE | A-S Medication Solutions | b7a4171c-7934-4723-a140-bd93ea84aae1 | 2023-11-21 | Warnings, Adverse reactions | Epinephrine EPINEPHRINE |
| Epinephrine | EPINEPHRINE | Medical Purchasing Solutions, LLC | 093312af-6eed-1f4b-e063-6294a90a155d | 2023-11-02 | Warnings, Adverse reactions | Epinephrine EPINEPHRINE |
| epinephrine | EPINEPHRINE | American Regent, Inc. | 6add7604-71f6-4d8a-9447-17ad01fa839d | 2023-10-01 | Warnings, Adverse reactions | epinephrine EPINEPHRINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 81472 | ORIG | 2025-03-06 |