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 44 .
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 · 88 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 2026-10-15 13:18:30 2026-09 N022110-001 VIBATIV EQ 250MG BASE/VIAL POWDER / INTRAVENOUS RLD 2009-09-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022110-002 VIBATIV EQ 750MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2009-09-11 c2088c7a36db…2026-09-14 22:38:34 2026-08 N022110-001 VIBATIV EQ 250MG BASE/VIAL POWDER / INTRAVENOUS RLD 2009-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022110-002 VIBATIV EQ 750MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2009-09-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022110-001 VIBATIV EQ 250MG BASE/VIAL POWDER / INTRAVENOUS RLD 2009-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022110-002 VIBATIV EQ 750MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2009-09-11 caaa826d4ba7…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…
Observed Orange Book patent history# Patent history page 2 of 8 · 316 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 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…2022-04-04 05:41 UTC 2022-04 N022110-001 6858584 2022-08-24 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022110-001 6635618 2023-09-11 U-728 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022110-001 7531623 2027-01-01 Drug substance 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022110-002 6858584 2022-08-24 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022110-002 6635618 2023-09-11 U-728 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022110-002 7531623 2027-01-01 Drug substance 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022110-001 7208471 2021-05-01 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022110-001 7351691 2021-05-01 U-728 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022110-001 7544364 2021-05-01 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022110-001 7700550 2021-05-01 U-282 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022110-001 8101575 2021-05-01 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022110-001 8158580 2021-05-01 Drug product 2012-04-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022110-001 7008923 2021-05-06 U-1005 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022110-001 6872701 2021-06-05 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022110-001 6858584 2022-08-24 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022110-001 6635618 2023-09-11 U-728 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022110-001 7531623 2027-01-01 Drug substance 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022110-002 7208471 2021-05-01 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022110-002 7351691 2021-05-01 U-728 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022110-002 7544364 2021-05-01 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022110-002 7700550 2021-05-01 U-282 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022110-002 8101575 2021-05-01 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022110-002 8158580 2021-05-01 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022110-002 7008923 2021-05-06 U-1005 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022110-002 6872701 2021-06-05 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022110-002 6858584 2022-08-24 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022110-002 6635618 2023-09-11 U-728 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022110-002 7531623 2027-01-01 Drug substance 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022110-001 6858584 2022-08-24 Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022110-001 6635618 2023-09-11 U-728 Drug substance, Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022110-001 7531623 2027-01-01 Drug substance bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022110-002 6858584 2022-08-24 Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022110-002 6635618 2023-09-11 U-728 Drug substance, Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022110-002 7531623 2027-01-01 Drug substance bb7c543d1eb4…
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
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 · 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