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| INJECTABLE;INJECTION | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |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| INJECTABLE;INJECTION | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |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| INJECTABLE;INJECTION | EQ 2GM BASE/VIAL **Federal Register determination that product was discontinued or withdrawn for safety or efficacy reasons** | No | No |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| INJECTABLE;INJECTION | EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |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| INJECTABLE;INJECTION | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |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| VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1986-07-22 | ||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| VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-03-30 | ||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| VANCOMYCIN HYDROCHLORIDE | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-05-11 | ||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| VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1988-05-11 | ||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 | Slate Run Pharmaceuticals, LLC | 57f58371-3ce6-4983-89df-acba33d1139a | 2026-05-15 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | GLENMARK PHARMACEUTICALS INC., USA | 74056e26-57fd-448e-af76-edbccfc3efb7 | 2026-04-07 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Civica, Inc | 3e041ec6-811b-4f26-9303-959cb09d5f57 | 2026-04-02 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | f2901045-904f-47bd-74a1-c561facd7f25 | 2026-04-01 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | c9ea31ec-4c26-452f-b07b-c5f894212cd5 | 2026-04-01 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | PAI Holdings, LLC dba PAI Pharma | ae6efaaf-37eb-4510-ba71-5f3dc3abdbd3 | 2026-03-31 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Plano Pharmaceuticals Inc. | 4983e3c8-e0f2-b366-e063-6394a90a9557 | 2026-03-25 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | ANI Pharmaceuticals, Inc. | 27d06545-1af0-4dcd-926d-58d4a9492ec3 | 2026-03-02 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| vancomycin hydrochloride | VANCOMYCIN HYDROCHLORIDE | ANI Pharmaceuticals, Inc. | 3707ad2e-5c82-4111-a370-e518e5e7e4c5 | 2026-03-02 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Plano Pharmaceuticals Inc. | 4983f60c-0f7b-d427-e063-6394a90a838c | 2026-02-24 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| vancomycin hydrochloride | VANCOMYCIN HYDROCHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ab658fbd-68ea-4275-84b1-c3361c860bd3 | 2026-02-11 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Gland Pharma Limited | 00946db3-d6c5-4534-a870-1ec6e63eda43 | 2026-01-30 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | XGen Pharmaceuticals DJB, Inc. | 4239165c-4c15-b78e-e063-6294a90ae6af | 2025-12-31 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | GLENMARK PHARMACEUTICALS INC., USA | 0543b2b5-b1c7-4ad6-b38c-3be0086f0e06 | 2025-12-23 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancocin | VANCOMYCIN HYDROCHLORIDE | ANI Pharmaceuticals, Inc. | a078d9c2-f89c-4f9f-8ded-60ffb2983c3f | 2025-12-22 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| vancomycin hydrochloride | VANCOMYCIN HYDROCHLORIDE | Redpharm Drug | 3745b502-c222-e307-e063-6394a90a697e | 2025-12-18 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| vancomycin hydrochloride | VANCOMYCIN HYDROCHLORIDE | Strides Pharma Science Limited | fac438bd-e08f-438d-ab64-426fc5c5450e | 2025-11-28 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Henry Schein, Inc. | 1bda7fa4-fdee-410a-a216-02cfbf91632f | 2025-11-07 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | STERISCIENCE SPECIALTIES PRIVATE LIMITED | 2c355037-6a1e-4846-872a-471ccbdc8d54 | 2025-10-31 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Civica, Inc | 50e4fb19-f603-439c-b193-25a455115383 | 2025-10-13 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.