Home Applications 214913 Application 214913
Type ANDA
Sponsor ALKEM LABS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE FOR SOLUTION;ORAL EQ 25MG BASE/ML No No 002 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE FOR SOLUTION;ORAL EQ 50MG BASE/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214913-001 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AA 2022-11-14 A214913-002 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AA 2022-11-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
Product history page 1 of 2 · 50 observed 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 2026-08-18 06:07:40 2026-07 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AA 2022-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AA 2022-11-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214913-001 VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214913-002 VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AB 2022-11-14 9b2671bbb829…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 50 observed states.
Observed Orange Book exclusivity history# 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.
Documents# Document, Submission type, Date table Document Submission type Date 72941 ORIG 2022-12-20