Application 090439

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDECAPSULE;ORALEQ 125MG BASENoNo
002VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDECAPSULE;ORALEQ 250MG BASENoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090439-001VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORAL2015-01-28
A090439-002VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORAL2015-01-28

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090439-001VANCOMYCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORAL2015-01-2884e616aacf4f…
2026-09-14 22:38:342026-08A090439-002VANCOMYCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORAL2015-01-2884e616aacf4f…
2026-08-18 06:07:402026-07A090439-001VANCOMYCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORAL2015-01-28caaa826d4ba7…
2026-08-18 06:07:402026-07A090439-002VANCOMYCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORAL2015-01-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090439-001VANCOMYCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALAB2015-01-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090439-002VANCOMYCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALAB2015-01-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090439-001VANCOMYCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALAB2015-01-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090439-002VANCOMYCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALAB2015-01-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A090439-001VANCOMYCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALAB2015-01-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090439-002VANCOMYCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALAB2015-01-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090439-001VANCOMYCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALAB2015-01-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090439-002VANCOMYCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALAB2015-01-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090439-001VANCOMYCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALAB2015-01-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090439-002VANCOMYCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALAB2015-01-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090439-001VANCOMYCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALAB2015-01-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090439-002VANCOMYCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALAB2015-01-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090439-001VANCOMYCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALAB2015-01-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090439-002VANCOMYCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALAB2015-01-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090439-001VANCOMYCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALAB2015-01-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090439-002VANCOMYCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALAB2015-01-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090439-001VANCOMYCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALAB2015-01-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090439-002VANCOMYCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALAB2015-01-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090439-001VANCOMYCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALAB2015-01-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A090439-002VANCOMYCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALAB2015-01-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090439-001VANCOMYCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALAB2015-01-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090439-002VANCOMYCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALAB2015-01-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090439-001VANCOMYCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALAB2015-01-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090439-002VANCOMYCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALAB2015-01-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090439-001VANCOMYCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALAB2015-01-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090439-002VANCOMYCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALAB2015-01-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090439-001VANCOMYCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALAB2015-01-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090439-002VANCOMYCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALAB2015-01-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090439-001VANCOMYCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALAB2015-01-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090439-002VANCOMYCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALAB2015-01-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090439-001VANCOMYCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALAB2015-01-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090439-002VANCOMYCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALAB2015-01-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090439-001VANCOMYCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALAB2015-01-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090439-002VANCOMYCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALAB2015-01-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090439-001VANCOMYCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALAB2015-01-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090439-002VANCOMYCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALAB2015-01-2874a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090439-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090439-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090439-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090439-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090439-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090439-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090439-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090439-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090439-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090439-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090439-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090439-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090439-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090439-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090439-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090439-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090439-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090439-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090439-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090439-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090439-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090439-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090439-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090439-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090439-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090439-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090439-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090439-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090439-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090439-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090439-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090439-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090439-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090439-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090439-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090439-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090439-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090439-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090439-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090439-002AB1782e0a99824c…

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 4 · 78 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDECameron Pharmaceuticalsbc737938-ae36-460b-a2a8-609f3fe591562026-08-17Warnings, Adverse reactionsName fallback
brand name: Vancomycin Hydrochloride
generic name: VANCOMYCIN HYDROCHLORIDE
vancomycin hydrochlorideVANCOMYCIN HYDROCHLORIDEAurobindo Pharma Limitede1008de0-8530-4998-8f8e-7d302e437e4f2026-08-17Warnings, Adverse reactionsName fallback
brand name: vancomycin hydrochloride
generic name: VANCOMYCIN HYDROCHLORIDE
vancomycin hydrochlorideVANCOMYCIN HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.127d95d1-8070-41ac-8343-3168b0cf13122026-08-05Warnings, Adverse reactionsName fallback
brand name: vancomycin hydrochloride
generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEAvenacy, LLCc757e65b-ca6f-4c00-afe2-025962b43d312026-07-31Warnings, Adverse reactionsName fallback
brand name: Vancomycin Hydrochloride
generic name: VANCOMYCIN HYDROCHLORIDE
vancomycin hydrochlorideVANCOMYCIN HYDROCHLORIDERedpharm Drug57d23aed-a3f7-f92e-e063-6394a90add7d2026-07-30Warnings, Adverse reactionsName fallback
brand name: vancomycin hydrochloride
generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.b01aaa02-8f1d-4b57-96a5-337503428af12026-07-20Warnings, Adverse reactionsName fallback
brand name: Vancomycin Hydrochloride
generic name: VANCOMYCIN HYDROCHLORIDE
FIRVANQVANCOMYCIN HYDROCHLORIDEAzurity Pharmaceuticals, Inc5aca5508-b577-446c-9980-ab4c7582b4b92026-07-14Warnings, Adverse reactionsName fallback
generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride for Oral SolutionVANCOMYCIN HYDROCHLORIDEWilshire Pharmaceuticals, Inc.4c3d2e99-5351-4442-916a-d2001b0a5f5a2026-07-14Warnings, Adverse reactionsName fallback
generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEMeitheal Pharmaceuticals Inc.033efc76-11d5-4a93-91de-56ed41bab9c32026-07-08Warnings, Adverse reactionsName fallback
brand name: Vancomycin Hydrochloride
generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEBryant Ranch Prepack7bbd2c81-33d9-4397-8795-8b9fa28cb5cf2026-06-26Warnings, Adverse reactionsName fallback
brand name: Vancomycin Hydrochloride
generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEBryant Ranch Prepackd6b8147b-5f93-49ee-8b27-78fe58987c902026-06-26Warnings, Adverse reactionsName fallback
brand name: Vancomycin Hydrochloride
generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEBryant Ranch Prepack28fe3c01-cf87-41c0-87fd-f93a405243352026-06-16Warnings, Adverse reactionsName fallback
brand name: Vancomycin Hydrochloride
generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEEurofarma, Inc.826510bd-b611-42d9-a574-ec7ee4151ef52026-06-12Warnings, Adverse reactionsName fallback
brand name: Vancomycin Hydrochloride
generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEBryant Ranch Prepack6c74b360-022a-4c4d-9e4b-0988219a78fb2026-06-12Warnings, Adverse reactionsName fallback
brand name: Vancomycin Hydrochloride
generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEBryant Ranch Prepack8193f588-a032-451e-a0a1-819a5ea834c82026-06-12Warnings, Adverse reactionsName fallback
brand name: Vancomycin Hydrochloride
generic name: VANCOMYCIN HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEBaxter Healthcare Corporation99e523d8-9bde-43cb-8434-497015e5dcbd2026-06-09Warnings, Adverse reactionsName fallback
brand name: VANCOMYCIN HYDROCHLORIDE
generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEBryant Ranch Prepacka09c589b-e7f4-457c-827f-e1bfa1b267002026-05-26Warnings, Adverse reactionsName fallback
brand name: Vancomycin Hydrochloride
generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEBryant Ranch Prepack786bde33-9aec-4b4d-ba46-90bfd61956d02026-05-26Warnings, Adverse reactionsName fallback
brand name: Vancomycin Hydrochloride
generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEBryant Ranch Prepack9b6a7a21-4fde-40c6-a420-a8546a4dc7012026-05-26Warnings, Adverse reactionsName fallback
brand name: Vancomycin Hydrochloride
generic name: VANCOMYCIN HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDESlate Run Pharmaceuticals, LLC6ea38b4d-a6d2-4826-8110-ae42c9f7a42a2026-05-15Warnings, Adverse reactionsName 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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68180-166VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDELupin Pharmaceuticals, Inc.ANDACurrent
68180-166VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDELupin Pharmaceuticals, Inc.ANDACurrent
68180-166VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDELupin Pharmaceuticals, Inc.ANDACurrent
68180-166VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDELupin Pharmaceuticals, Inc.ANDACurrent
68180-166VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDELupin Pharmaceuticals, Inc.ANDACurrent
68180-167VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDELupin Pharmaceuticals, Inc.ANDACurrent
68180-167VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDELupin Pharmaceuticals, Inc.ANDACurrent
68180-167VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDELupin Pharmaceuticals, Inc.ANDACurrent
68180-167VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDELupin Pharmaceuticals, Inc.ANDACurrent
68180-167VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDELupin Pharmaceuticals, Inc.ANDACurrent