Application 210274
- Type
- NDA
- Sponsor
- ZHEJAING NOVUS PHARMACEUTICALS CO. LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | 500MG/VIAL | No | No |
| 002 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | 1GRAM/VIAL | No | No |
| 003 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | 5GRAM/VIAL | No | No |
| 004 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | 10GRAM/VIAL | No | No |
| 005 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | POWDER;INTRAVENOUS, ORAL | EQ 750MG BASE/VIAL | Yes | Yes |
| 006 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | POWDER;INTRAVENOUS, ORAL | EQ 1.25GM BASE/VIAL | Yes | Yes |
| 007 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | POWDER;INTRAVENOUS, ORAL | EQ 1.5MG BASE/VIAL | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N210274-001 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | |
| N210274-002 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | |
| N210274-003 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | |
| N210274-004 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | |
| N210274-005 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2025-08-01 | |
| N210274-006 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1.25GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2025-08-01 | |
| N210274-007 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1.5MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2025-08-01 |
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 | N210274-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210274-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210274-003 | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210274-004 | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210274-005 | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2025-08-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210274-006 | VANCOMYCIN HYDROCHLORIDE | EQ 1.25GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2025-08-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210274-007 | VANCOMYCIN HYDROCHLORIDE | EQ 1.5MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2025-08-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210274-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210274-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210274-003 | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210274-004 | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210274-005 | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2025-08-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210274-006 | VANCOMYCIN HYDROCHLORIDE | EQ 1.25GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2025-08-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210274-007 | VANCOMYCIN HYDROCHLORIDE | EQ 1.5MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2025-08-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210274-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210274-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210274-003 | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210274-004 | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210274-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210274-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210274-003 | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210274-004 | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210274-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210274-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210274-003 | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210274-004 | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210274-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210274-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210274-003 | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210274-004 | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210274-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210274-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210274-003 | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210274-004 | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N210274-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N210274-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N210274-003 | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N210274-004 | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N210274-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N210274-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | d8e5a09893c0… |
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 | HIKMA PHARMACEUTICALS USA INC. | 8eccafe8-40c9-495a-872d-7f45a98ee759 | 2025-08-13 | Warnings, Adverse reactions | 210274 NDA210274 |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | HIKMA PHARMACEUTICALS USA INC. | e4ce7b87-fab4-4b7a-b121-eba136c464ce | 2024-08-07 | Warnings, Adverse reactions | 210274 NDA210274 |