Application 062956
- Type
- ANDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VANCOR | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No |
| 002 | VANCOR | VANCOMYCIN HYDROCHLORIDE | 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 |
|---|---|---|---|---|---|---|---|
| A062956-001 | VANCOR | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | ||
| A062956-002 | VANCOR | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A062956-001 | VANCOR | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062956-002 | VANCOR | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062956-001 | VANCOR | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062956-002 | VANCOR | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062956-001 | VANCOR | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062956-002 | VANCOR | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062956-001 | VANCOR | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062956-002 | VANCOR | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062956-001 | VANCOR | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062956-002 | VANCOR | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062956-001 | VANCOR | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062956-002 | VANCOR | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062956-001 | VANCOR | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062956-002 | VANCOR | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062956-001 | VANCOR | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062956-002 | VANCOR | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062956-001 | VANCOR | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062956-002 | VANCOR | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062956-001 | VANCOR | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062956-002 | VANCOR | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062956-001 | VANCOR | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062956-002 | VANCOR | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A062956-001 | VANCOR | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A062956-002 | VANCOR | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062956-001 | VANCOR | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062956-002 | VANCOR | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062956-001 | VANCOR | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062956-002 | VANCOR | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062956-001 | VANCOR | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062956-002 | VANCOR | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A062956-001 | VANCOR | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A062956-002 | VANCOR | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062956-001 | VANCOR | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062956-002 | VANCOR | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A062956-001 | VANCOR | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A062956-002 | VANCOR | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A062956-001 | VANCOR | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A062956-002 | VANCOR | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A062956-001 | VANCOR | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A062956-002 | VANCOR | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 74a2ff9319b5… |
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 | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Sagent Pharmaceuticals | f623889c-a47a-4b3a-b3a9-e04051f5c2df | 2025-05-28 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | f604d399-fded-4f4f-8efe-af558ed07b9d | 2025-05-15 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Gland Pharma Limited | 65e5f2ee-934c-40d7-967c-00d085f84ffd | 2025-04-24 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| vancomycin hydrochloride | VANCOMYCIN HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 33127951-1fad-15c1-e063-6294a90a6996 | 2025-04-18 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | b62b7190-48e8-4596-a6ad-9ad455e5c8c6 | 2025-03-21 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | 9bfe30f8-c662-4af3-bc82-f0102eef8952 | 2025-03-17 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | 91c050cf-3b2d-48bc-7297-e8dc68225e5a | 2025-01-16 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | 83ea3faf-fedd-4725-911f-d71a23ec5d5e | 2024-10-15 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | HIKMA PHARMACEUTICALS USA INC. | e4ce7b87-fab4-4b7a-b121-eba136c464ce | 2024-08-07 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin | VANCOMYCIN HYDROCHLORIDE | Sagent Pharmaceuticals | 06dcfd36-942f-4752-86ad-4c5a6fc3e48f | 2024-07-19 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Eugia US LLC | 4a80cb3f-7410-47aa-af1f-ff83d1b35c55 | 2024-07-08 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Eugia US LLC | 78984781-3c0b-4b73-ba85-10d60ecb2a28 | 2024-07-08 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Mylan Institutional LLC | 40a88420-5fcb-4715-abc5-595a18fd08d0 | 2024-06-07 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Mylan Institutional LLC | caf22ccb-df75-45ea-a1d0-ccb2d37272fb | 2024-06-07 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Xellia Pharmaceuticals USA LLC | 8403695c-3614-490b-9797-6c5ebcdeef9b | 2023-12-12 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Meitheal Pharmaceuticals Inc. | 45642a47-4712-4a12-8cf7-ee6c2ab8e6c6 | 2023-09-29 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | 0576803d-95de-4a48-806a-69ae3fcaf6b0 | 2023-08-17 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin hydrochloride | VANCOMYCIN HYDROCHLORIDE | Eugia US LLC | 9aa42538-c84e-4886-8d3d-a7dfded5120f | 2023-08-05 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Gland Pharma Limited | 35ecffbc-77d8-4c0d-9b14-6a3cc442dec6 | 2023-07-13 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.