Application 062604
- Type
- ANDA
- Sponsor
- ABRAXIS PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ERYTHROMYCIN LACTOBIONATE | ERYTHROMYCIN LACTOBIONATE | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No |
| 002 | ERYTHROMYCIN LACTOBIONATE | ERYTHROMYCIN LACTOBIONATE | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A062604-001 | ERYTHROMYCIN LACTOBIONATE | ERYTHROMYCIN LACTOBIONATE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1986-11-24 | ||
| A062604-002 | ERYTHROMYCIN LACTOBIONATE | ERYTHROMYCIN LACTOBIONATE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1986-11-24 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | A062604-001 | ERYTHROMYCIN LACTOBIONATE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1986-11-24 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A062604-002 | ERYTHROMYCIN LACTOBIONATE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1986-11-24 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A062604-001 | ERYTHROMYCIN LACTOBIONATE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1986-11-24 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A062604-002 | ERYTHROMYCIN LACTOBIONATE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1986-11-24 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A062604-001 | ERYTHROMYCIN LACTOBIONATE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1986-11-24 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A062604-002 | ERYTHROMYCIN LACTOBIONATE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1986-11-24 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A062604-001 | ERYTHROMYCIN LACTOBIONATE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1986-11-24 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A062604-002 | ERYTHROMYCIN LACTOBIONATE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1986-11-24 | 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 |
|---|---|---|---|---|---|---|
| Erythromycin Lactobionate | ERYTHROMYCIN LACTOBIONATE | Piramal Critical Care Inc. | ee345752-0f0c-c69b-e053-2995a90a7dac | 2026-08-16 | Warnings, Adverse reactions | Erythromycin Lactobionate ERYTHROMYCIN LACTOBIONATE |
| Erythromycin Lactobionate | ERYTHROMYCIN LACTOBIONATE | Armas Pharmaceuticals Inc. | ca65a48f-5fe6-4b31-8359-51dbc31f6d4e | 2026-07-09 | Warnings, Adverse reactions | Erythromycin Lactobionate ERYTHROMYCIN LACTOBIONATE |
| Erythrocin Lactobionate | ERYTHROMYCIN LACTOBIONATE | Hospira, Inc. | a96c405f-bd70-4bb4-719e-ac6a79dcc213 | 2025-10-30 | Warnings, Adverse reactions | ERYTHROMYCIN LACTOBIONATE |
| erythromycin lactobionate | ERYTHROMYCIN LACTOBIONATE | Gland Pharma Limited | c6f9565b-6d9d-40e3-87f8-9f38ede9173a | 2024-11-20 | Warnings, Adverse reactions | erythromycin lactobionate ERYTHROMYCIN LACTOBIONATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.