Application 215324
- Type
- ANDA
- Sponsor
- STERISCIENCE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | POWDER;INTRAVENOUS | EQ 750MG BASE/VIAL | No | No |
| 002 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | POWDER;INTRAVENOUS | EQ 1.25GM BASE/VIAL | No | No |
| 003 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | POWDER;INTRAVENOUS | EQ 1.5GM BASE/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A215324-001 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/VIAL | POWDER / INTRAVENOUS | AP | 2025-10-02 | |
| A215324-002 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1.25GM BASE/VIAL | POWDER / INTRAVENOUS | AP | 2025-10-02 | |
| A215324-003 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1.5GM BASE/VIAL | POWDER / INTRAVENOUS | AP | 2025-10-02 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A215324-001 | AP |
| A215324-002 | AP |
| A215324-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A215324-001 | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/VIAL | POWDER / INTRAVENOUS | AP | 2025-10-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215324-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1.25GM BASE/VIAL | POWDER / INTRAVENOUS | AP | 2025-10-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215324-003 | VANCOMYCIN HYDROCHLORIDE | EQ 1.5GM BASE/VIAL | POWDER / INTRAVENOUS | AP | 2025-10-02 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215324-001 | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/VIAL | POWDER / INTRAVENOUS | AP | 2025-10-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215324-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1.25GM BASE/VIAL | POWDER / INTRAVENOUS | AP | 2025-10-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215324-003 | VANCOMYCIN HYDROCHLORIDE | EQ 1.5GM BASE/VIAL | POWDER / INTRAVENOUS | AP | 2025-10-02 | 31067a03dcf5… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215324-001 | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/VIAL | POWDER / INTRAVENOUS | AP | 2025-10-02 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215324-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1.25GM BASE/VIAL | POWDER / INTRAVENOUS | AP | 2025-10-02 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215324-003 | VANCOMYCIN HYDROCHLORIDE | EQ 1.5GM BASE/VIAL | POWDER / INTRAVENOUS | AP | 2025-10-02 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A215324-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215324-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215324-003 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215324-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215324-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215324-003 | AP | 1 | 31067a03dcf5… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215324-001 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215324-002 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215324-003 | 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 |
|---|---|---|---|---|---|---|
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | XGen Pharmaceuticals DJB, Inc. | 4239165c-4c15-b78e-e063-6294a90ae6af | 2025-12-31 | Warnings, Adverse reactions | 215324 ANDA215324 |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | STERISCIENCE SPECIALTIES PRIVATE LIMITED | 2c355037-6a1e-4846-872a-471ccbdc8d54 | 2025-10-31 | Warnings, Adverse reactions | 215324 ANDA215324 |