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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A062956-001 | VANCOR | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A062956-002 | VANCOR | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A062956-001 | VANCOR | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A062956-002 | VANCOR | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1988-08-01 | 782e0a99824c… |
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 | Redpharm Drug | 57d23aed-a3f7-f92e-e063-6394a90add7d | 2026-07-30 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | b01aaa02-8f1d-4b57-96a5-337503428af1 | 2026-07-20 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| FIRVANQ | VANCOMYCIN HYDROCHLORIDE | Azurity Pharmaceuticals, Inc | 5aca5508-b577-446c-9980-ab4c7582b4b9 | 2026-07-14 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride for Oral Solution | VANCOMYCIN HYDROCHLORIDE | Wilshire Pharmaceuticals, Inc. | 4c3d2e99-5351-4442-916a-d2001b0a5f5a | 2026-07-14 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Meitheal Pharmaceuticals Inc. | 033efc76-11d5-4a93-91de-56ed41bab9c3 | 2026-07-08 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Bryant Ranch Prepack | 7bbd2c81-33d9-4397-8795-8b9fa28cb5cf | 2026-06-26 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Bryant Ranch Prepack | d6b8147b-5f93-49ee-8b27-78fe58987c90 | 2026-06-26 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Bryant Ranch Prepack | 28fe3c01-cf87-41c0-87fd-f93a40524335 | 2026-06-16 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Eurofarma, Inc. | 826510bd-b611-42d9-a574-ec7ee4151ef5 | 2026-06-12 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Bryant Ranch Prepack | 6c74b360-022a-4c4d-9e4b-0988219a78fb | 2026-06-12 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Bryant Ranch Prepack | 8193f588-a032-451e-a0a1-819a5ea834c8 | 2026-06-12 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Baxter Healthcare Corporation | 99e523d8-9bde-43cb-8434-497015e5dcbd | 2026-06-09 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Bryant Ranch Prepack | a09c589b-e7f4-457c-827f-e1bfa1b26700 | 2026-05-26 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Bryant Ranch Prepack | 786bde33-9aec-4b4d-ba46-90bfd61956d0 | 2026-05-26 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Bryant Ranch Prepack | 9b6a7a21-4fde-40c6-a420-a8546a4dc701 | 2026-05-26 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Slate Run Pharmaceuticals, LLC | 6ea38b4d-a6d2-4826-8110-ae42c9f7a42a | 2026-05-15 | Warnings, Adverse reactions | VANCOMYCIN HYDROCHLORIDE |
| 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 | Cameron Pharmaceuticals | bc737938-ae36-460b-a2a8-609f3fe59156 | 2026-04-14 | 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 |