Home Applications 206334 Application 206334
Type NDA
Sponsor MELINTA THERAP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ORBACTIV ORITAVANCIN DIPHOSPHATE POWDER;INTRAVENOUS EQ 400MG BASE/VIAL Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N206334-001 ORBACTIV ORITAVANCIN DIPHOSPHATE EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206334-001 12514899 2029-08-29 U-4398 2026-02-03 N206334-001 8420592 2029-08-29 U-1570 2014-09-17 N206334-001 9682061 2030-04-26 U-1569 2017-07-20 N206334-001 9649352 2035-07-16 Drug product 2017-06-14
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 · 43 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 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 4 · 139 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N206334-001 12514899 2029-08-29 U-4398 2026-02-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206334-001 8420592 2029-08-29 U-1570 2014-09-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206334-001 9682061 2030-04-26 U-1569 2017-07-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206334-001 9649352 2035-07-16 Drug product 2017-06-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N206334-001 12514899 2029-08-29 U-4398 2026-02-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206334-001 8420592 2029-08-29 U-1570 2014-09-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206334-001 9682061 2030-04-26 U-1569 2017-07-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206334-001 9649352 2035-07-16 Drug product 2017-06-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206334-001 12514899 2029-08-29 U-4398 2026-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206334-001 8420592 2029-08-29 U-1570 2014-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206334-001 9682061 2030-04-26 U-1569 2017-07-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206334-001 9649352 2035-07-16 Drug product 2017-06-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206334-001 8420592 2029-08-29 U-1570 2014-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206334-001 9682061 2030-04-26 U-1569 2017-07-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206334-001 9649352 2035-07-16 Drug product 2017-06-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206334-001 8420592 2029-08-29 U-1570 2014-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206334-001 9682061 2030-04-26 U-1569 2017-07-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206334-001 9649352 2035-07-16 Drug product 2017-06-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206334-001 8420592 2029-08-29 U-1570 2014-09-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206334-001 9682061 2030-04-26 U-1569 2017-07-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206334-001 9649352 2035-07-16 Drug product 2017-06-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206334-001 8420592 2029-08-29 U-1570 2014-09-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206334-001 9682061 2030-04-26 U-1569 2017-07-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206334-001 9649352 2035-07-16 Drug product 2017-06-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206334-001 8420592 2029-08-29 U-1570 2014-09-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206334-001 9682061 2030-04-26 U-1569 2017-07-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206334-001 9649352 2035-07-16 Drug product 2017-06-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206334-001 8420592 2029-08-29 U-1570 2014-09-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206334-001 9682061 2030-04-26 U-1569 2017-07-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206334-001 9649352 2035-07-16 Drug product 2017-06-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206334-001 8420592 2029-08-29 U-1570 2014-09-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206334-001 9682061 2030-04-26 U-1569 2017-07-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206334-001 9649352 2035-07-16 Drug product 2017-06-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206334-001 8420592 2029-08-29 U-1570 2014-09-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206334-001 9682061 2030-04-26 U-1569 2017-07-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206334-001 9649352 2035-07-16 Drug product 2017-06-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206334-001 8420592 2029-08-29 U-1570 2014-09-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N206334-001 9682061 2030-04-26 U-1569 2017-07-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N206334-001 9649352 2035-07-16 Drug product 2017-06-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206334-001 8420592 2029-08-29 U-1570 2014-09-17 79d66fd596c7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 70 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.
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 · 11 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 65293-015 Orbactiv oritavancin The Medicines Company NDA Current 65293-015 Orbactiv oritavancin The Medicines Company NDA Current 65293-015 Orbactiv oritavancin The Medicines Company NDA Current 70842-140 Orbactiv oritavancin Melinta Therapeutics, Inc. NDA Current 70842-140 Orbactiv oritavancin Melinta Therapeutics, LLC NDA Current 70842-140 Orbactiv oritavancin Melinta Therapeutics, Inc. NDA Current 70842-140 Orbactiv oritavancin Melinta Therapeutics, LLC NDA Current 70842-140 Orbactiv oritavancin Melinta Therapeutics, Inc. NDA Current 70842-140 Orbactiv oritavancin Melinta Therapeutics, LLC NDA Current 70842-140 Orbactiv oritavancin Melinta Therapeutics, LLC NDA Current 70842-140 Orbactiv oritavancin Melinta Therapeutics, Inc. NDA Current