Home Applications 215338 Application 215338
Type ANDA
Sponsor AMNEAL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE FOR SOLUTION;ORAL EQ 250MG BASE/5ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215338-001 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/5ML FOR SOLUTION / ORAL 2023-06-23
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 table 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 A215338-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/5ML FOR SOLUTION / ORAL 2023-06-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215338-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/5ML FOR SOLUTION / ORAL 2023-06-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215338-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/5ML FOR SOLUTION / ORAL 2023-06-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215338-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/5ML FOR SOLUTION / ORAL AA 2023-06-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215338-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/5ML FOR SOLUTION / ORAL AA 2023-06-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215338-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/5ML FOR SOLUTION / ORAL AA 2023-06-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215338-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/5ML FOR SOLUTION / ORAL AA 2023-06-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215338-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/5ML FOR SOLUTION / ORAL AA 2023-06-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215338-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/5ML FOR SOLUTION / ORAL AA 2023-06-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215338-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/5ML FOR SOLUTION / ORAL AA 2023-06-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215338-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/5ML FOR SOLUTION / ORAL AA 2023-06-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215338-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/5ML FOR SOLUTION / ORAL AA 2023-06-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215338-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/5ML FOR SOLUTION / ORAL AA 2023-06-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215338-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/5ML FOR SOLUTION / ORAL AA 2023-06-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215338-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/5ML FOR SOLUTION / ORAL AA 2023-06-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215338-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/5ML FOR SOLUTION / ORAL AA 2023-06-23 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215338-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/5ML FOR SOLUTION / ORAL AA 2023-06-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215338-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/5ML FOR SOLUTION / ORAL AA 2023-06-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215338-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/5ML FOR SOLUTION / ORAL AA 2023-06-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215338-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/5ML FOR SOLUTION / ORAL AA 2023-06-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215338-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/5ML FOR SOLUTION / ORAL AA 2023-06-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215338-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/5ML FOR SOLUTION / ORAL AA 2023-06-23 a67488948f0b…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215338-001 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/5ML FOR SOLUTION / ORAL 2023-06-23 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2023-12-20 04:57 UTC 2023-12 A215338-001 CGT 2023-12-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215338-001 CGT 2023-12-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215338-001 CGT 2023-12-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215338-001 CGT 2023-12-20 a67488948f0b…
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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.