Application 019884

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MESNEX	MESNA	INJECTABLE;INTRAVENOUS	100MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N019884-001	MESNEX	MESNA	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N019884-001	AP

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 · 42 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
2026-08-18 06:07:40	2026-07	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N019884-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019884-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019884-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019884-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019884-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019884-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019884-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019884-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019884-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019884-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019884-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019884-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019884-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019884-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019884-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019884-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019884-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019884-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019884-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019884-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019884-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019884-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019884-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019884-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019884-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019884-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019884-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019884-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019884-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019884-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019884-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019884-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019884-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019884-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019884-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019884-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019884-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019884-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019884-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019884-001	AP	1	`e64feba35796…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MESNEX	MESNA	Bamboo US Bidco LCC	1dd69e84-616d-fb77-e063-6394a90af2f4	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019884 application number: NDA019884
MESNEX	MESNA	Baxter Healthcare Company	49fdfbc3-69f8-4706-9d11-bf60e4e7811b	2018-12-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019884 application number: NDA019884 ndc (product): 0338-1305
MESNA	MESNA	Baxter Healthcare Company	fe1683ef-0569-411e-8188-0499884632ad	2018-12-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019884 application number: NDA019884 ndc (product): 10019-953
MESNA	MESNA	Baxter Healthcare Company	a880160b-fa82-453a-a971-29ab897876a7	2018-12-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019884 application number: NDA019884 ndc (product): 10019-951
MESNEX	MESNA	Baxter Healthcare Company	2e8eebc3-ea75-4c57-bfe1-2c5dc2c37806	2018-07-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019884 application number: NDA019884 ndc (product): 0338-1307

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-1305	MESNEX	mesna	Baxter Healthcare Corporation	NDA	Current
0338-1305	MESNEX	mesna	Baxter Healthcare Corporation	NDA	Current
0338-1305	MESNEX	mesna	Baxter Healthcare Corporation	NDA	Current
0338-1305	MESNEX	mesna	Baxter Healthcare Corporation	NDA	Current
0338-1307	MESNEX	MESNA	Baxter Healthcare Corporation	NDA	Current
0338-1307	MESNEX	MESNA	Baxter Healthcare Corporation	NDA	Current
10019-951	MESNA	MESNA	Baxter Healthcare Corporation	NDA	Current
10019-951	MESNA	MESNA	Baxter Healthcare Corporation	NDA	Current
10019-951	MESNA	MESNA	Baxter Healthcare Corporation	NDA	Current
10019-951	MESNA	MESNA	Baxter Healthcare Corporation	NDA	Current
10019-953	MESNA	MESNA	Baxter Healthcare Corporation	NDA	Current
10019-953	MESNA	MESNA	Baxter Healthcare Corporation	NDA	Current
10019-953	MESNA	MESNA	Baxter Healthcare Corporation	NDA	Current
10019-953	MESNA	MESNA	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56920	SUPPL	2018-12-21
56760	SUPPL	2018-12-18
11806	SUPPL	2014-03-19
1751	SUPPL	2014-03-19
19789	SUPPL	2003-01-30
1750	SUPPL	2003-01-30