Application 208610

Type: NDA
Sponsor: MELINTA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BAXDELA	DELAFLOXACIN MEGLUMINE	TABLET;ORAL	EQ 450MG BASE	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
N208610-001	BAXDELA	DELAFLOXACIN MEGLUMINE	EQ 450MG BASE	TABLET / ORAL		RLD, RS	2017-06-19

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208610-001	8273892	2026-08-06		Drug substance	2017-07-18
N208610-001	8252813	2026-10-02	U-2028	Drug product	2017-07-18
N208610-001	8871938	2029-09-23		Drug substance	2017-07-18
N208610-001	RE46617	2029-12-28		Drug substance	2017-12-21
N208610-001	7728143	2031-06-19		Drug substance	2017-07-18

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N208610-001	NCE	2022-06-19
N208610-001	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208610-001	BAXDELA	EQ 450MG BASE	TABLET / ORAL	RLD, RS	2017-06-19	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 332 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	N208610-001	8273892	2026-08-06		Drug substance	2017-07-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208610-001	8252813	2026-10-02	U-2028	Drug product	2017-07-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208610-001	8871938	2029-09-23		Drug substance	2017-07-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208610-001	RE46617	2029-12-28		Drug substance	2017-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208610-001	7728143	2031-06-19		Drug substance	2017-07-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208610-001	8273892	2026-08-06		Drug substance	2017-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208610-001	8252813	2026-10-02	U-2028	Drug product	2017-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208610-001	8871938	2029-09-23		Drug substance	2017-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208610-001	RE46617	2029-12-28		Drug substance	2017-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208610-001	7728143	2031-06-19		Drug substance	2017-07-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208610-001	8273892	2026-08-06		Drug substance	2017-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208610-001	8252813	2026-10-02	U-2028	Drug product	2017-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208610-001	8871938	2029-09-23		Drug substance	2017-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208610-001	RE46617	2029-12-28		Drug substance	2017-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208610-001	7728143	2031-06-19		Drug substance	2017-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208610-001	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	N208610-001	8969569	2025-10-07	U-2028	Drug product	2017-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208610-001	9539250	2025-10-07	U-2028	Drug substance, Drug product	2017-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208610-001	8273892	2026-08-06		Drug substance	2017-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208610-001	8252813	2026-10-02	U-2028	Drug product	2017-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208610-001	8871938	2029-09-23		Drug substance	2017-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208610-001	RE46617	2029-12-28		Drug substance	2017-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208610-001	7728143	2031-06-19		Drug substance	2017-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208610-001	8648093	2025-10-07	U-2028	Drug product	2017-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208610-001	8969569	2025-10-07	U-2028	Drug product	2017-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208610-001	9539250	2025-10-07	U-2028	Drug substance, Drug product	2017-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208610-001	8273892	2026-08-06		Drug substance	2017-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208610-001	8252813	2026-10-02	U-2028	Drug product	2017-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208610-001	8871938	2029-09-23		Drug substance	2017-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208610-001	RE46617	2029-12-28		Drug substance	2017-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208610-001	7728143	2031-06-19		Drug substance	2017-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208610-001	8648093	2025-10-07	U-2028	Drug product	2017-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208610-001	8969569	2025-10-07	U-2028	Drug product	2017-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208610-001	9539250	2025-10-07	U-2028	Drug substance, Drug product	2017-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208610-001	8273892	2026-08-06		Drug substance	2017-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208610-001	8252813	2026-10-02	U-2028	Drug product	2017-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208610-001	8871938	2029-09-23		Drug substance	2017-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208610-001	RE46617	2029-12-28		Drug substance	2017-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208610-001	7728143	2031-06-19		Drug substance	2017-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208610-001	8648093	2025-10-07	U-2028	Drug product	2017-07-18	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Exclusivity history page 2 of 3 · 101 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-04-04 05:41 UTC	2022-04	N208610-001	GAIN	2027-06-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208610-001	NCE	2022-06-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208610-001	GAIN	2027-06-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208610-001	NCE	2022-06-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208610-001	I-815	2022-10-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208610-001	GAIN	2027-06-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208610-001	NCE	2022-06-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208610-001	I-815	2022-10-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208610-001	GAIN	2027-06-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208610-001	NCE	2022-06-19	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208610-001	I-815	2022-10-24	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208610-001	GAIN	2027-06-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208610-001	NCE	2022-06-19	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208610-001	I-815	2022-10-24	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208610-001	GAIN	2027-06-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208610-001	NCE	2022-06-19	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208610-001	I-815	2022-10-24	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208610-001	GAIN	2027-06-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208610-001	NCE	2022-06-19	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208610-001	I-815	2022-10-24	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208610-001	GAIN	2027-06-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208610-001	NCE	2022-06-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208610-001	I-815	2022-10-24	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208610-001	GAIN	2027-06-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208610-001	NCE	2022-06-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208610-001	GAIN	2027-06-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208610-001	NCE	2022-06-19	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208610-001	GAIN	2027-06-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208610-001	NCE	2022-06-19	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208610-001	GAIN	2027-06-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208610-001	NCE	2022-06-19	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N208610-001	GAIN	2027-06-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208610-001	NCE	2022-06-19	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N208610-001	GAIN	2027-06-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208610-001	NCE	2022-06-19	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208610-001	GAIN	2027-06-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208610-001	NCE	2022-06-19	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208610-001	GAIN	2027-06-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208610-001	NCE	2022-06-19	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208610-001	GAIN	2027-06-19	`a67488948f0b…`

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): 208610 application number: NDA208610 ndc (product): 70842-101

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
70842-101	Baxdela	delafloxacin meglumine	Melinta Therapeutics, LLC	NDA	Current
70842-101	Baxdela	delafloxacin meglumine	Melinta Therapeutics, Inc	NDA	Current
70842-101	Baxdela	delafloxacin meglumine	Melinta Therapeutics, Inc	NDA	Current
70842-101	Baxdela	delafloxacin meglumine	Melinta Therapeutics, Inc	NDA	Current
70842-101	Baxdela	delafloxacin meglumine	Melinta Therapeutics, LLC	NDA	Current
70842-101	Baxdela	delafloxacin meglumine	Melinta Therapeutics, Inc	NDA	Current
70842-101	Baxdela	delafloxacin meglumine	Melinta Therapeutics, LLC	NDA	Current
70842-101	Baxdela	delafloxacin meglumine	Melinta Therapeutics, Inc	NDA	Current
70842-101	Baxdela	delafloxacin meglumine	Melinta Therapeutics, LLC	NDA	Current
70842-101	Baxdela	delafloxacin meglumine	Melinta Therapeutics, Inc	NDA	Current
70842-101	Baxdela	delafloxacin meglumine	Melinta Therapeutics, Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
60677	SUPPL	2019-10-25
60676	SUPPL	2019-10-25
60672	SUPPL	2019-10-25
58742	SUPPL	2019-05-16
58739	SUPPL	2019-05-16
58589	SUPPL	2019-05-07
56074	SUPPL	2018-10-23
56021	SUPPL	2018-10-19
49058	ORIG	2017-07-25
48769	ORIG	2017-06-19
48766	ORIG	2017-06-19