Home Applications 208611 Application 208611
Type NDA
Sponsor MELINTA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BAXDELA DELAFLOXACIN MEGLUMINE POWDER;INTRAVENOUS EQ 300MG 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 N208611-001 BAXDELA DELAFLOXACIN MEGLUMINE EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19
Orange Book patents# Current patent rows page 1 of 1 · 13 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208611-001 8273892 2026-08-06 Drug substance 2017-07-18 N208611-001 8252813 2026-10-02 U-2028 Drug product 2017-07-18 N208611-001 7635773 2029-03-13 Drug product 2017-12-21 N208611-001 8410077 2029-03-13 Drug product 2017-12-21 N208611-001 9200088 2029-03-13 Drug product 2017-12-21 N208611-001 9750822 2029-03-13 Drug product 2017-12-21 N208611-001 8871938 2029-09-23 Drug substance 2017-07-18 N208611-001 RE46617 2029-12-28 Drug substance 2017-12-21 N208611-001 7728143 2031-06-19 Drug substance 2017-07-18 N208611-001 12138257 2032-05-01 Drug product 2024-11-14 N208611-001 9493582 2033-02-27 Drug product 2017-12-21 N208611-001 12558349 2034-03-14 U-3967 2026-03-19 N208611-001 12036219 2034-06-02 U-3967 2024-07-30
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N208611-001 NCE 2022-06-19 N208611-001 GAIN 2027-06-19
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 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 14 · 535 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 N208611-001 8273892 2026-08-06 Drug substance 2017-07-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208611-001 8252813 2026-10-02 U-2028 Drug product 2017-07-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208611-001 7635773 2029-03-13 Drug product 2017-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208611-001 8410077 2029-03-13 Drug product 2017-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208611-001 9200088 2029-03-13 Drug product 2017-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208611-001 9750822 2029-03-13 Drug product 2017-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208611-001 8871938 2029-09-23 Drug substance 2017-07-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208611-001 RE46617 2029-12-28 Drug substance 2017-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208611-001 7728143 2031-06-19 Drug substance 2017-07-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208611-001 12138257 2032-05-01 Drug product 2024-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208611-001 9493582 2033-02-27 Drug product 2017-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208611-001 12558349 2034-03-14 U-3967 2026-03-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208611-001 12036219 2034-06-02 U-3967 2024-07-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208611-001 8273892 2026-08-06 Drug substance 2017-07-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208611-001 8252813 2026-10-02 U-2028 Drug product 2017-07-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208611-001 7635773 2029-03-13 Drug product 2017-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208611-001 8410077 2029-03-13 Drug product 2017-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208611-001 9200088 2029-03-13 Drug product 2017-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208611-001 9750822 2029-03-13 Drug product 2017-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208611-001 8871938 2029-09-23 Drug substance 2017-07-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208611-001 RE46617 2029-12-28 Drug substance 2017-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208611-001 7728143 2031-06-19 Drug substance 2017-07-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208611-001 12138257 2032-05-01 Drug product 2024-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208611-001 9493582 2033-02-27 Drug product 2017-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208611-001 12558349 2034-03-14 U-3967 2026-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208611-001 12036219 2034-06-02 U-3967 2024-07-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208611-001 8273892 2026-08-06 Drug substance 2017-07-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208611-001 8252813 2026-10-02 U-2028 Drug product 2017-07-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208611-001 7635773 2029-03-13 Drug product 2017-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208611-001 8410077 2029-03-13 Drug product 2017-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208611-001 9200088 2029-03-13 Drug product 2017-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208611-001 9750822 2029-03-13 Drug product 2017-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208611-001 8871938 2029-09-23 Drug substance 2017-07-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208611-001 RE46617 2029-12-28 Drug substance 2017-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208611-001 7728143 2031-06-19 Drug substance 2017-07-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208611-001 12138257 2032-05-01 Drug product 2024-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208611-001 9493582 2033-02-27 Drug product 2017-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208611-001 12036219 2034-06-02 U-3967 2024-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208611-001 8648093 2025-10-07 U-2028 Drug product 2017-07-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208611-001 9539250 2025-10-07 U-2028 Drug substance, Drug product 2017-07-18 31067a03dcf5…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Baxdela DELAFLOXACIN MEGLUMINE Melinta Therapeutics, LLC fb77637a-88d9-4aea-958f-e270030ce30d 2025-08-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 208611 application number: NDA208611 ndc (product): 70842-102
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 70842-102 Baxdela delafloxacin meglumine Melinta Therapeutics, LLC NDA Current 70842-102 Baxdela delafloxacin meglumine Melinta Therapeutics, Inc NDA Current 70842-102 Baxdela delafloxacin meglumine Melinta Therapeutics, Inc NDA Current 70842-102 Baxdela delafloxacin meglumine Melinta Therapeutics, Inc NDA Current 70842-102 Baxdela delafloxacin meglumine Melinta Therapeutics, LLC NDA Current 70842-102 Baxdela delafloxacin meglumine Melinta Therapeutics, Inc NDA Current 70842-102 Baxdela delafloxacin meglumine Melinta Therapeutics, LLC NDA Current 70842-102 Baxdela delafloxacin meglumine Melinta Therapeutics, Inc NDA Current 70842-102 Baxdela delafloxacin meglumine Melinta Therapeutics, LLC NDA Current 70842-102 Baxdela delafloxacin meglumine Melinta Therapeutics, Inc NDA Current 70842-102 Baxdela delafloxacin meglumine Melinta Therapeutics, Inc NDA Current