Application 073590

Type: ANDA
Sponsor: ROXANE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LACTULOSE	LACTULOSE	SOLUTION;ORAL, RECTAL	10GM/15ML	No	No

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
A073590-001	LACTULOSE	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL			1992-05-29

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073590-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	1992-05-29	`f41ea6bd6efb…`

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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Constulose	LACTULOSE	Actavis Pharma, Inc.	461ec39f-eeb4-4460-9b5c-62367d47162b	2022-06-01	Warnings, Adverse reactions	Name fallback generic name: LACTULOSE
Enulose	LACTULOSE	Actavis Pharma, Inc.	00c42c5c-d19e-4130-aa08-a8bbd47d3e5b	2022-06-01	Warnings, Adverse reactions	Name fallback generic name: LACTULOSE
LACTULOSE	LACTULOSE	Lannett Company, Inc.	6619b25c-26b7-4c43-8c4f-9d33a23c61ca	2020-01-30	Warnings, Adverse reactions	Name fallback brand name: LACTULOSE generic name: LACTULOSE
KRISTALOSE	LACTULOSE	Cumberland Pharmaceuticals Inc.	535dd1ea-b567-49f7-9a84-8ea91e78c466	2018-09-17	Warnings, Adverse reactions	Name fallback generic name: LACTULOSE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.