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 | Sagent Pharmaceuticals | 4843726f-6e79-6e20-2620-4a54616e6479 | 2023-06-29 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Ascend Laboratories, LLC | b9a7c728-750b-467f-bf61-54dd836dba1b | 2023-06-28 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Amneal Pharmaceuticals NY LLC | 3c47d5c4-8cdb-4701-8d7a-8a6e79025b53 | 2023-06-23 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin hydrochloride | VANCOMYCIN HYDROCHLORIDE | Meitheal Pharmaceuticals Inc. | e5e26614-4119-40cc-b092-48ab97a41287 | 2023-03-27 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | 0713a847-a334-4b73-af22-343aa06621b9 | 2023-02-07 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi, LLC | 8a35ebee-8650-4ef5-84f5-ab9b55d9bc19 | 2022-12-02 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi, LLC | 418c3c6a-d08d-448c-89c9-54e558c1ce16 | 2022-12-02 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | BluePoint Laboratories | f28e3c2b-ae31-4c2a-8178-53962b7b213c | 2022-09-22 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Camber Pharmaceuticals, Inc. | 3f5dacea-af40-4103-b128-c5e0c0c52fa1 | 2022-07-20 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 86950e7c-0114-47e9-8891-e09e595c48c3 | 2022-02-25 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | cae9e5f3-b89a-4a7f-93f7-9471c74a3559 | 2021-12-07 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | d3147f2d-1a72-4923-874b-8fdee2be625e | 2021-09-30 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Mylan Institutional LLC | ce139a51-0471-4c31-b456-2f889f18dd2b | 2021-09-15 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 2f5d3131-8ddc-43a5-91f7-947c531796e7 | 2021-06-02 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Mylan Institutional LLC | 2dc7b3d6-3874-40ac-b8aa-7bcfe2dc0cdf | 2021-06-01 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| vancomycin hydrochloride | VANCOMYCIN HYDROCHLORIDE | Mylan Institutional LLC | 3843d0d7-f70a-4b29-9478-dfb45b02425e | 2021-06-01 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | SAMSON MEDICAL TECHNOLOGIES LLC | 93589e71-3a11-4797-9176-8abdb7674a87 | 2020-11-29 | Boxed warning, Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi, LLC | a7e7d990-1d74-459b-ac07-d1c3e13b3204 | 2019-01-09 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.