Home Applications 022110 Application 022110
Type NDA
Sponsor CUMBERLAND PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VIBATIV TELAVANCIN HYDROCHLORIDE POWDER;INTRAVENOUS EQ 250MG BASE/VIAL Yes No 002 VIBATIV TELAVANCIN HYDROCHLORIDE POWDER;INTRAVENOUS EQ 750MG BASE/VIAL Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N022110-001 VIBATIV TELAVANCIN HYDROCHLORIDE EQ 250MG BASE/VIAL POWDER / INTRAVENOUS RLD 2009-09-11 N022110-002 VIBATIV TELAVANCIN HYDROCHLORIDE EQ 750MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2009-09-11
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022110-001 7531623 2027-01-01 Drug substance N022110-002 7531623 2027-01-01 Drug substance
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 · 82 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 2026-02-19 14:30 UTC 2026-02 N022110-001 VIBATIV EQ 250MG BASE/VIAL POWDER / INTRAVENOUS RLD 2009-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022110-002 VIBATIV EQ 750MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2009-09-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022110-001 VIBATIV EQ 250MG BASE/VIAL POWDER / INTRAVENOUS RLD 2009-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022110-002 VIBATIV EQ 750MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2009-09-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022110-001 VIBATIV EQ 250MG BASE/VIAL POWDER / INTRAVENOUS RLD 2009-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022110-002 VIBATIV EQ 750MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2009-09-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022110-001 VIBATIV EQ 250MG BASE/VIAL POWDER / INTRAVENOUS RLD 2009-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022110-002 VIBATIV EQ 750MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2009-09-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022110-001 VIBATIV EQ 250MG BASE/VIAL POWDER / INTRAVENOUS RLD 2009-09-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022110-002 VIBATIV EQ 750MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2009-09-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022110-001 VIBATIV EQ 250MG BASE/VIAL POWDER / INTRAVENOUS RLD 2009-09-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022110-002 VIBATIV EQ 750MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2009-09-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022110-001 VIBATIV EQ 250MG BASE/VIAL POWDER / INTRAVENOUS RLD 2009-09-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022110-002 VIBATIV EQ 750MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2009-09-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022110-001 VIBATIV EQ 250MG BASE/VIAL POWDER / INTRAVENOUS RLD 2009-09-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022110-002 VIBATIV EQ 750MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2009-09-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022110-001 VIBATIV EQ 250MG BASE/VIAL POWDER / INTRAVENOUS RLD 2009-09-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022110-002 VIBATIV EQ 750MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2009-09-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022110-001 VIBATIV EQ 250MG BASE/VIAL POWDER / INTRAVENOUS RLD 2009-09-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022110-002 VIBATIV EQ 750MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2009-09-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022110-001 VIBATIV EQ 250MG BASE/VIAL POWDER / INTRAVENOUS RLD 2009-09-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022110-002 VIBATIV EQ 750MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2009-09-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022110-001 VIBATIV EQ 250MG BASE/VIAL POWDER / INTRAVENOUS RLD 2009-09-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022110-002 VIBATIV EQ 750MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2009-09-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022110-001 VIBATIV EQ 250MG BASE/VIAL POWDER / INTRAVENOUS RLD 2009-09-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022110-002 VIBATIV EQ 750MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2009-09-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022110-001 VIBATIV EQ 250MG BASE/VIAL POWDER / INTRAVENOUS RLD 2009-09-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022110-002 VIBATIV EQ 750MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2009-09-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022110-001 VIBATIV EQ 250MG BASE/VIAL POWDER / INTRAVENOUS RLD 2009-09-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022110-002 VIBATIV EQ 750MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2009-09-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022110-001 VIBATIV EQ 250MG BASE/VIAL POWDER / INTRAVENOUS RLD 2009-09-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022110-002 VIBATIV EQ 750MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2009-09-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022110-001 VIBATIV EQ 250MG BASE/VIAL POWDER / INTRAVENOUS RLD 2009-09-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022110-002 VIBATIV EQ 750MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2009-09-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022110-001 VIBATIV EQ 250MG BASE/VIAL POWDER / INTRAVENOUS RLD 2009-09-11 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022110-002 VIBATIV EQ 750MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2009-09-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022110-001 VIBATIV EQ 250MG BASE/VIAL POWDER / INTRAVENOUS RLD 2009-09-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022110-002 VIBATIV EQ 750MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2009-09-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022110-001 VIBATIV EQ 250MG BASE/VIAL POWDER / INTRAVENOUS RLD 2009-09-11 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022110-002 VIBATIV EQ 750MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2009-09-11 782e0a99824c…
Observed Orange Book patent history# Patent history page 1 of 8 · 310 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022110-001 7531623 2027-01-01 Drug substance 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022110-002 7531623 2027-01-01 Drug substance 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022110-001 7531623 2027-01-01 Drug substance 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022110-002 7531623 2027-01-01 Drug substance 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022110-001 7531623 2027-01-01 Drug substance 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022110-002 7531623 2027-01-01 Drug substance 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022110-001 7531623 2027-01-01 Drug substance fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022110-002 7531623 2027-01-01 Drug substance fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022110-001 7531623 2027-01-01 Drug substance b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022110-002 7531623 2027-01-01 Drug substance b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022110-001 7531623 2027-01-01 Drug substance 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022110-002 7531623 2027-01-01 Drug substance 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022110-001 7531623 2027-01-01 Drug substance 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022110-002 7531623 2027-01-01 Drug substance 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022110-001 7531623 2027-01-01 Drug substance 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022110-002 7531623 2027-01-01 Drug substance 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022110-001 7531623 2027-01-01 Drug substance d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022110-002 7531623 2027-01-01 Drug substance d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022110-001 7531623 2027-01-01 Drug substance d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022110-002 7531623 2027-01-01 Drug substance d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022110-001 7531623 2027-01-01 Drug substance 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022110-002 7531623 2027-01-01 Drug substance 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022110-001 7531623 2027-01-01 Drug substance 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022110-002 7531623 2027-01-01 Drug substance 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022110-001 7531623 2027-01-01 Drug substance 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022110-002 7531623 2027-01-01 Drug substance 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022110-001 7531623 2027-01-01 Drug substance 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022110-002 7531623 2027-01-01 Drug substance 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022110-001 6858584 2022-08-24 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022110-001 6635618 2023-09-11 U-728 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022110-001 7531623 2027-01-01 Drug substance 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022110-002 6858584 2022-08-24 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022110-002 6635618 2023-09-11 U-728 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022110-002 7531623 2027-01-01 Drug substance 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022110-001 6858584 2022-08-24 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022110-001 6635618 2023-09-11 U-728 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022110-001 7531623 2027-01-01 Drug substance 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022110-002 6858584 2022-08-24 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022110-002 6635618 2023-09-11 U-728 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022110-002 7531623 2027-01-01 Drug substance 5d02ea3f76ae…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VIBATIV TELAVANCIN HYDROCHLORIDE Cumberland Pharmaceuticals Inc. 5359b759-db7c-4672-9e8a-59c93869bd91 2025-12-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022110 application number: NDA022110 ndc (product): 66220-315
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 52118-001 Vibativ telavancin hydrochloride Theravance, Inc. NDA Current 52118-002 Vibativ telavancin hydrochloride Theravance, Inc. NDA Current 62847-001 Vibativ telavancin hydrochloride Theravance Biopharma R&D, Inc. NDA Current 62847-001 Vibativ telavancin hydrochloride Theravance Biopharma R&D, Inc. NDA Current 62847-001 Vibativ telavancin hydrochloride Theravance Biopharma R&D, Inc. NDA Current 62847-001 Vibativ telavancin hydrochloride Theravance Biopharma R&D, Inc. NDA Current 62847-002 Vibativ telavancin hydrochloride Theravance Biopharma R&D, Inc. NDA Current 66220-315 VIBATIV telavancin hydrochloride Cumberland Pharmaceuticals Inc. NDA Current