Application 065397
- Type
- ANDA
- Sponsor
- MYLAN LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No |
| 002 | VANCOMYCIN HYDROCHLORIDE | 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 |
|---|---|---|---|---|---|---|---|
| A065397-001 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | |
| A065397-002 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065397-001 | AP |
| A065397-002 | AP |
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 | A065397-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A065397-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A065397-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A065397-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065397-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065397-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065397-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065397-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065397-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065397-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065397-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065397-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065397-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065397-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065397-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065397-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065397-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065397-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065397-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065397-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065397-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065397-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065397-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065397-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065397-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065397-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065397-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065397-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065397-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065397-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065397-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065397-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065397-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065397-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065397-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065397-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065397-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065397-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065397-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065397-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-12-30 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-09-29 23:25 UTC | 2022-09 | A065397-001 | AP | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A065397-002 | AP | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A065397-001 | AP | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A065397-002 | AP | 1 | cb3db0bc1861… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A065397-001 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A065397-002 | AP | 1 | a50c72e98297… |
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 | Mylan Institutional LLC | 2dc7b3d6-3874-40ac-b8aa-7bcfe2dc0cdf | 2021-06-01 | Warnings, Adverse reactions | 065397 ANDA065397 67457-340 67457-339 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 21695-424 | Sterile Vancomycin Hydrochloride | Vancomycin Hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 67457-339 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-339 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-340 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-340 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-611 | vancomycin hydrochloride | vancomycin hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-611 | vancomycin hydrochloride | vancomycin hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-611 | vancomycin hydrochloride | vancomycin hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-612 | vancomycin hydrochloride | vancomycin hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-612 | vancomycin hydrochloride | vancomycin hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-612 | vancomycin hydrochloride | vancomycin hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 82449-803 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | STERISCIENCE SPECIALTIES PRIVATE LIMITED | ANDA | Current |
| 82449-804 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | STERISCIENCE SPECIALTIES PRIVATE LIMITED | ANDA | Current |