Application 018749

Type: NDA
Sponsor: MISSION PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LITHOSTAT	ACETOHYDROXAMIC ACID	TABLET;ORAL	250MG	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
N018749-001	LITHOSTAT	ACETOHYDROXAMIC ACID	250MG	TABLET / ORAL		RLD, RS	1983-05-31

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018749-001	LITHOSTAT	250MG	TABLET / ORAL	RLD, RS	1983-05-31	`cb3db0bc1861…`

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
Lithostat	ACETOHYDROXAMIC ACID	Mission Pharmacal Company	6660b616-a82d-9109-19ce-2bdf9747acea	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018749 application number: NDA018749 ndc (product): 0178-0500

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
0178-0500	Lithostat	acetohydroxamic acid	Mission Pharmacal Company	NDA	Current
0178-0500	Lithostat	acetohydroxamic acid	Mission Pharmacal Company	NDA	Current
0178-0500	Lithostat	acetohydroxamic acid	Mission Pharmacal Company	NDA	Current
0178-0500	Lithostat	acetohydroxamic acid	Mission Pharmacal Company	NDA	Current