Application 219692
- Type
- ANDA
- Sponsor
- SAGENT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE | NOREPINEPHRINE BITARTRATE | SOLUTION;INTRAVENOUS | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | No | No |
| 002 | NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE | NOREPINEPHRINE BITARTRATE | SOLUTION;INTRAVENOUS | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A219692-001 | NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE | NOREPINEPHRINE BITARTRATE | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2025-08-11 | |
| A219692-002 | NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE | NOREPINEPHRINE BITARTRATE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2025-08-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A219692-001 | AP |
| A219692-002 | 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 | A219692-001 | NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2025-08-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A219692-002 | NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2025-08-11 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219692-001 | NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2025-08-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219692-002 | NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2025-08-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219692-001 | NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2025-08-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219692-002 | NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2025-08-11 | 31067a03dcf5… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219692-001 | NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2025-08-11 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219692-002 | NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2025-08-11 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A219692-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A219692-002 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A219692-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A219692-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219692-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219692-002 | AP | 1 | 31067a03dcf5… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219692-001 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219692-002 | 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 |
|---|---|---|---|---|---|---|
| NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | HF Acquisition Co LLC, DBA HealthFirst | c90d875c-8e6e-284e-e053-2a95a90a334f | 2026-06-19 | Warnings, Adverse reactions | NOREPINEPHRINE BITARTRATE |
| NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE | NOREPINEPHRINE BITARTRATE | WG Critical Care, LLC | ddbef60d-c20a-4ada-928f-e87074c08a54 | 2026-02-17 | Warnings, Adverse reactions | NOREPINEPHRINE BITARTRATE |
| NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | Baxter Healthcare Corporation | 6363e9b4-29df-4553-904d-a563e5adda6e | 2026-02-06 | Warnings, Adverse reactions | NOREPINEPHRINE BITARTRATE |
| norepinephrine bitartrate | NOREPINEPHRINE BITARTRATE | Avenacy, LLC | dd4b7827-2fe9-4427-a40a-60f275611bf4 | 2026-02-01 | Warnings, Adverse reactions | NOREPINEPHRINE BITARTRATE |
| norepinephrine bitartrate | NOREPINEPHRINE BITARTRATE | Novadoz Pharmaceuticals LLC | 4b054c27-ed64-40e2-8eba-b7f2ec780a82 | 2025-12-16 | Warnings, Adverse reactions | NOREPINEPHRINE BITARTRATE |
| Norepinephrine | NOREPINEPHRINE BITARTRATE | Long Grove Pharmaceuticals, LLC | 759807dd-61a8-4f6f-8bf5-f6ee773c81bc | 2025-12-04 | Warnings, Adverse reactions | NOREPINEPHRINE BITARTRATE |
| NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | Anthea Pharma Private Limited | 52e22892-4fc3-4f53-9f39-0b5c66da3040 | 2025-11-25 | Warnings, Adverse reactions | NOREPINEPHRINE BITARTRATE |
| Norepinephrine Bitartrate | NOREPINEPHRINE BITARTRATE | Breckenridge Pharmaceutical, Inc. | 109aa5e6-4e42-4131-97b0-f24d3a4cb4e8 | 2025-10-06 | Warnings, Adverse reactions | NOREPINEPHRINE BITARTRATE |
| NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | BIOCON PHARMA INC. | 0ea48ab6-e166-df31-b132-70ef982a2d02 | 2025-06-17 | Warnings, Adverse reactions | NOREPINEPHRINE BITARTRATE |
| LEVOPHED | NOREPINEPHRINE BITARTRATE | Hospira, Inc. | 2c7dd2b0-cc10-4db6-bf56-6eb154ebeb10 | 2025-06-12 | Warnings, Adverse reactions | NOREPINEPHRINE BITARTRATE |
| Norepinephrine bitartrate | NOREPINEPHRINE BITARTRATE | Camber Pharmaceuticals, Inc. | baba1002-8b62-4a24-a4e1-53e7a59c785a | 2025-06-12 | Warnings, Adverse reactions | NOREPINEPHRINE BITARTRATE |
| LEVOPHED | NOREPINEPHRINE BITARTRATE | Hospira, Inc. | c4de72a8-2a75-4984-ce90-e4870226dc12 | 2025-06-12 | Warnings, Adverse reactions | NOREPINEPHRINE BITARTRATE |
| Norepinephrine Bitartrate | NOREPINEPHRINE BITARTRATE | Amneal Pharmaceuticals LLC | 256264b1-ddf6-42b7-8a09-194fffea65e2 | 2025-04-24 | Warnings, Adverse reactions | NOREPINEPHRINE BITARTRATE |
| Norepinephrine Bitartrate | NOREPINEPHRINE BITARTRATE | Rising Pharma Holdings, Inc. | e6669ed6-9ebc-4b2d-9a8c-5e318fbd18b4 | 2024-11-01 | Warnings, Adverse reactions | NOREPINEPHRINE BITARTRATE |
| NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | Caplin Steriles Limited | 2ffda6e7-d45d-4af3-a3b1-250a4c95e736 | 2024-09-28 | Warnings, Adverse reactions | NOREPINEPHRINE BITARTRATE |
| Norepinephrine Bitartrate | NOREPINEPHRINE BITARTRATE | Meitheal Pharmaceuticals Inc. | 53578ac5-b510-4698-a097-f785bfea9fc0 | 2024-06-24 | Warnings, Adverse reactions | NOREPINEPHRINE BITARTRATE |
| Norepinephrine bitartrate | NOREPINEPHRINE BITARTRATE | Gland Pharma Limited | dec04acd-8e66-43c7-80b0-468802eba093 | 2024-05-24 | Warnings, Adverse reactions | NOREPINEPHRINE BITARTRATE |
| Norepinephrine Bitartrate | NOREPINEPHRINE BITARTRATE | Hikma Pharmaceuticals USA Inc. | 39cda6c6-3857-4028-80cf-aef135f8c7e6 | 2024-01-10 | Warnings, Adverse reactions | NOREPINEPHRINE BITARTRATE |
| Norepinephrine Bitartrate | NOREPINEPHRINE BITARTRATE | Sagent Pharmaceuticals | cc9ecec5-3bd7-4132-9745-7666bac8ceac | 2023-12-31 | Warnings, Adverse reactions | NOREPINEPHRINE BITARTRATE |
| Norepinephrine Bitartrate | NOREPINEPHRINE BITARTRATE | BE Pharmaceuticals Inc. | c42d425a-094e-4390-b4f9-4bb4b0fbc7d0 | 2023-12-30 | Warnings, Adverse reactions | NOREPINEPHRINE BITARTRATE |