Home Applications 090439 Application 090439
Type ANDA
Sponsor LUPIN LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 125MG BASE No No 002 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 250MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A090439-001 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL 2015-01-28 A090439-002 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL 2015-01-28
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 3 · 86 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 2026-09-14 22:38:34 2026-08 A090439-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL 2015-01-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090439-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL 2015-01-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090439-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL 2015-01-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090439-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL 2015-01-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090439-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2015-01-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090439-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2015-01-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090439-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2015-01-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090439-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2015-01-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090439-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2015-01-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090439-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2015-01-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090439-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2015-01-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090439-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2015-01-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090439-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2015-01-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090439-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2015-01-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090439-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2015-01-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090439-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2015-01-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090439-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2015-01-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090439-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2015-01-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090439-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2015-01-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090439-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2015-01-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090439-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2015-01-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090439-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2015-01-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090439-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2015-01-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090439-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2015-01-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090439-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2015-01-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090439-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2015-01-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090439-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2015-01-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090439-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2015-01-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090439-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2015-01-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090439-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2015-01-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090439-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2015-01-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090439-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2015-01-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090439-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2015-01-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090439-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2015-01-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090439-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2015-01-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090439-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2015-01-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090439-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2015-01-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090439-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2015-01-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090439-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2015-01-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090439-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2015-01-28 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.
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 3 of 4 · 78 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE HIKMA PHARMACEUTICALS USA INC. 8eccafe8-40c9-495a-872d-7f45a98ee759 2025-08-13 Warnings, Adverse reactions Name fallback brand name: VANCOMYCIN HYDROCHLORIDE generic name: VANCOMYCIN HYDROCHLORIDE Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Sagent Pharmaceuticals f623889c-a47a-4b3a-b3a9-e04051f5c2df 2025-05-28 Warnings, Adverse reactions Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE Fresenius Kabi USA, LLC f604d399-fded-4f4f-8efe-af558ed07b9d 2025-05-15 Warnings, Adverse reactions Name fallback brand name: VANCOMYCIN HYDROCHLORIDE generic name: VANCOMYCIN HYDROCHLORIDE Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Gland Pharma Limited 65e5f2ee-934c-40d7-967c-00d085f84ffd 2025-04-24 Warnings, Adverse reactions Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride VANCOMYCIN HYDROCHLORIDE Advanced Rx of Tennessee, LLC 33127951-1fad-15c1-e063-6294a90a6996 2025-04-18 Warnings, Adverse reactions Name fallback brand name: vancomycin hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Hikma Pharmaceuticals USA Inc. b62b7190-48e8-4596-a6ad-9ad455e5c8c6 2025-03-21 Warnings, Adverse reactions Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Fresenius Kabi USA, LLC 9bfe30f8-c662-4af3-bc82-f0102eef8952 2025-03-17 Warnings, Adverse reactions Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Hospira, Inc. 91c050cf-3b2d-48bc-7297-e8dc68225e5a 2025-01-16 Warnings, Adverse reactions Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE Fresenius Kabi USA, LLC 83ea3faf-fedd-4725-911f-d71a23ec5d5e 2024-10-15 Warnings, Adverse reactions Name fallback brand name: VANCOMYCIN HYDROCHLORIDE generic name: VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE HIKMA PHARMACEUTICALS USA INC. e4ce7b87-fab4-4b7a-b121-eba136c464ce 2024-08-07 Warnings, Adverse reactions Name fallback brand name: VANCOMYCIN HYDROCHLORIDE generic name: VANCOMYCIN HYDROCHLORIDE Vancomycin VANCOMYCIN HYDROCHLORIDE Sagent Pharmaceuticals 06dcfd36-942f-4752-86ad-4c5a6fc3e48f 2024-07-19 Warnings, Adverse reactions Name fallback generic name: VANCOMYCIN HYDROCHLORIDE Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Eugia US LLC 4a80cb3f-7410-47aa-af1f-ff83d1b35c55 2024-07-08 Warnings, Adverse reactions Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Eugia US LLC 78984781-3c0b-4b73-ba85-10d60ecb2a28 2024-07-08 Warnings, Adverse reactions Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Mylan Institutional LLC 40a88420-5fcb-4715-abc5-595a18fd08d0 2024-06-07 Warnings, Adverse reactions Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Mylan Institutional LLC caf22ccb-df75-45ea-a1d0-ccb2d37272fb 2024-06-07 Warnings, Adverse reactions Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Xellia Pharmaceuticals USA LLC 8403695c-3614-490b-9797-6c5ebcdeef9b 2023-12-12 Warnings, Adverse reactions Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Meitheal Pharmaceuticals Inc. 45642a47-4712-4a12-8cf7-ee6c2ab8e6c6 2023-09-29 Warnings, Adverse reactions Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE Fresenius Kabi USA, LLC 0576803d-95de-4a48-806a-69ae3fcaf6b0 2023-08-17 Warnings, Adverse reactions Name fallback brand name: VANCOMYCIN HYDROCHLORIDE generic name: VANCOMYCIN HYDROCHLORIDE Vancomycin hydrochloride VANCOMYCIN HYDROCHLORIDE Eugia US LLC 9aa42538-c84e-4886-8d3d-a7dfded5120f 2023-08-05 Warnings, Adverse reactions Name fallback brand name: Vancomycin hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Gland Pharma Limited 35ecffbc-77d8-4c0d-9b14-6a3cc442dec6 2023-07-13 Warnings, Adverse reactions Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68180-166 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE Lupin Pharmaceuticals, Inc. ANDA Current 68180-166 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE Lupin Pharmaceuticals, Inc. ANDA Current 68180-166 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE Lupin Pharmaceuticals, Inc. ANDA Current 68180-166 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE Lupin Pharmaceuticals, Inc. ANDA Current 68180-166 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE Lupin Pharmaceuticals, Inc. ANDA Current 68180-167 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE Lupin Pharmaceuticals, Inc. ANDA Current 68180-167 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE Lupin Pharmaceuticals, Inc. ANDA Current 68180-167 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE Lupin Pharmaceuticals, Inc. ANDA Current 68180-167 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE Lupin Pharmaceuticals, Inc. ANDA Current 68180-167 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE Lupin Pharmaceuticals, Inc. ANDA Current