Home Applications 021883 Application 021883
Type NDA
Sponsor ALLERGAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DALVANCE DALBAVANCIN HYDROCHLORIDE POWDER;INTRAVENOUS EQ 500MG 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021883-001 DALVANCE DALBAVANCIN HYDROCHLORIDE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2014-05-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021883-001 AP
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021883-001 6900175 2028-05-23 U-3499 2014-06-13
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 · 41 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 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2014-05-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2014-05-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 cb3db0bc1861…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021883-001 AP 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021883-001 AP 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021883-001 AP 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 113 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 N021883-001 6900175 2028-05-23 U-3499 2014-06-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021883-001 6900175 2028-05-23 U-3499 2014-06-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021883-001 6900175 2028-05-23 U-3499 2014-06-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021883-001 6900175 2028-05-23 U-3499 2014-06-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021883-001 6900175 2028-05-23 U-3499 2014-06-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021883-001 6900175 2028-05-23 U-3499 2014-06-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021883-001 6900175 2028-05-23 U-3499 2014-06-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021883-001 6900175 2028-05-23 U-3499 2014-06-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021883-001 6900175 2028-05-23 U-3499 2014-06-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021883-001 6900175 2028-05-23 U-3499 2014-06-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021883-001 6900175 2028-05-23 U-3499 2014-06-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021883-001 6900175 2028-05-23 U-3499 2014-06-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021883-001 6900175 2028-05-23 U-3499 2014-06-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021883-001 6900175 2028-05-23 U-3499 2014-06-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021883-001 7115564 2023-11-14 Drug product 2014-06-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021883-001 7119061 2023-11-14 Drug product 2014-06-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021883-001 8143212 2023-11-14 U-1517 2014-06-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021883-001 6900175 2023-12-25 U-1517 2014-06-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021883-001 7115564 2023-11-14 Drug product 2014-06-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021883-001 7119061 2023-11-14 Drug product 2014-06-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021883-001 8143212 2023-11-14 U-1517 2014-06-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021883-001 6900175 2023-12-25 U-1517 2014-06-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021883-001 7115564 2023-11-14 Drug product 2014-06-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021883-001 7119061 2023-11-14 Drug product 2014-06-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021883-001 8143212 2023-11-14 U-1517 2014-06-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021883-001 6900175 2023-12-25 U-1517 2014-06-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021883-001 7115564 2023-11-14 Drug product 2014-06-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021883-001 7119061 2023-11-14 Drug product 2014-06-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021883-001 8143212 2023-11-14 U-1517 2014-06-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021883-001 6900175 2023-12-25 U-1517 2014-06-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021883-001 7115564 2023-11-14 Drug product 2014-06-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021883-001 7119061 2023-11-14 Drug product 2014-06-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021883-001 8143212 2023-11-14 U-1517 2014-06-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021883-001 6900175 2023-12-25 U-1517 2014-06-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021883-001 7115564 2023-11-14 Drug product 2014-06-13 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021883-001 7119061 2023-11-14 Drug product 2014-06-13 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021883-001 8143212 2023-11-14 U-1517 2014-06-13 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021883-001 6900175 2023-12-25 U-1517 2014-06-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021883-001 7115564 2023-11-14 Drug product 2014-06-13 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021883-001 7119061 2023-11-14 Drug product 2014-06-13 87673890dc5c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 101 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 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 57970-100 DALVANCE Dalbavancin Allergan, Inc. NDA Current 57970-100 DALVANCE Dalbavancin Allergan, Inc. NDA Current 57970-100 DALVANCE Dalbavancin Durata Therapeutics Inc. NDA Current 57970-100 DALVANCE Dalbavancin Allergan, Inc. NDA Current