Application 062682
- Type
- ANDA
- Sponsor
- WEST-WARD PHARMS INT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VANCOLED | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 002 | VANCOLED | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 003 | VANCOLED | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL **Federal Register determination that product was discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 004 | VANCOLED | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 005 | VANCOLED | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A062682-001 | VANCOLED | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1986-07-22 | ||
| A062682-002 | VANCOLED | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-03-30 | ||
| A062682-003 | VANCOLED | VANCOMYCIN HYDROCHLORIDE | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-05-11 | ||
| A062682-004 | VANCOLED | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-05-11 | ||
| A062682-005 | VANCOLED | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-05-11 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A062682-001 | VANCOLED | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1986-07-22 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A062682-002 | VANCOLED | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-03-30 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A062682-003 | VANCOLED | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-05-11 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A062682-004 | VANCOLED | EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-05-11 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A062682-005 | VANCOLED | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-05-11 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062682-001 | VANCOLED | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1986-07-22 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062682-002 | VANCOLED | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-03-30 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062682-003 | VANCOLED | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-05-11 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062682-004 | VANCOLED | EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-05-11 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062682-005 | VANCOLED | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-05-11 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062682-001 | VANCOLED | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1986-07-22 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062682-002 | VANCOLED | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-03-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062682-003 | VANCOLED | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-05-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062682-004 | VANCOLED | EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-05-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062682-005 | VANCOLED | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-05-11 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062682-001 | VANCOLED | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1986-07-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062682-002 | VANCOLED | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-03-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062682-003 | VANCOLED | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-05-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062682-004 | VANCOLED | EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-05-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062682-005 | VANCOLED | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-05-11 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062682-001 | VANCOLED | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1986-07-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062682-002 | VANCOLED | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-03-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062682-003 | VANCOLED | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-05-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062682-004 | VANCOLED | EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-05-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062682-005 | VANCOLED | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-05-11 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062682-001 | VANCOLED | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1986-07-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062682-002 | VANCOLED | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-03-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062682-003 | VANCOLED | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-05-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062682-004 | VANCOLED | EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-05-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062682-005 | VANCOLED | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-05-11 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062682-001 | VANCOLED | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1986-07-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062682-002 | VANCOLED | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-03-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062682-003 | VANCOLED | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-05-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062682-004 | VANCOLED | EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-05-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062682-005 | VANCOLED | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-05-11 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062682-001 | VANCOLED | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1986-07-22 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062682-002 | VANCOLED | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-03-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062682-003 | VANCOLED | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-05-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062682-004 | VANCOLED | EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-05-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062682-005 | VANCOLED | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-05-11 | b8a1b40f171c… |
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.