Application 090426

Type: ANDA
Sponsor: ANI PHARMS

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 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
A090426-001	LACTULOSE	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL			2008-11-21

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	2008-11-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	2008-11-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	2008-11-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	2008-11-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090426-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2008-11-21	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A090426-001	AA	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A090426-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090426-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090426-001	AA	1	`ea99ee380514…`

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lactulose	LACTULOSE	APOZEAL PHARMACEUTICALS INC	72ac130a-de85-464d-9e9b-05cac0c54db1	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: Lactulose generic name: LACTULOSE
Lactulose	LACTULOSE	PAI Holdings, LLC dba PAI Pharma	5ae4b6da-44df-419a-9f2b-8c4d79f635c8	2026-07-07	Warnings, Adverse reactions	Name fallback brand name: Lactulose generic name: LACTULOSE
LACTULOSE	LACTULOSE	Cardinal Health 107, LLC	3cf3ff7c-67e7-42a9-8ebb-bd6c53937dd7	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: LACTULOSE generic name: LACTULOSE
Lactulose	LACTULOSE	Xttrium Laboratories, Inc.	df62ad54-5aba-4d05-e053-2a95a90aa48d	2026-04-14	Warnings, Adverse reactions	Name fallback brand name: Lactulose generic name: LACTULOSE
Lactulose	LACTULOSE	Chartwell RX, LLC	d6975cd8-80e0-43e2-809a-175ea7e40715	2026-01-28	Warnings, Adverse reactions	Name fallback brand name: Lactulose generic name: LACTULOSE
Lactulose	LACTULOSE	APOZEAL PHARMACEUTICALS INC	a8af7389-3699-4873-b05a-509af7e8eaab	2026-01-06	Warnings, Adverse reactions	Name fallback brand name: Lactulose generic name: LACTULOSE
Lactulose	LACTULOSE	Foxland Pharmaceuticals, Inc.	3363bdbd-f0d1-45b3-8193-7fdb0a310cc2	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: Lactulose generic name: LACTULOSE
Lactulose	LACTULOSE	Chartwell RX, LLC.	bd9f1577-65e8-4521-b176-e5fc60a4a018	2025-12-08	Warnings, Adverse reactions	Name fallback brand name: Lactulose generic name: LACTULOSE
Lactulose	LACTULOSE	Chartwell Governmental & Specialty RX, LLC.	887157ba-3c91-4fbf-bb12-b49c6fa4252c	2025-11-13	Warnings, Adverse reactions	Name fallback brand name: Lactulose generic name: LACTULOSE
LACTULOSE	LACTULOSE	Atlantic Biologicals Corp.	3fb6e908-893c-5a57-e063-6294a90a1bfc	2025-09-26	Warnings, Adverse reactions	Name fallback brand name: LACTULOSE generic name: LACTULOSE
LACTULOSE	LACTULOSE	PAI Holdings, LLC dba PAI Pharma	0f19e4ed-c90a-4330-a7fa-bf911aa98f09	2025-09-15	Warnings, Adverse reactions	Name fallback brand name: LACTULOSE generic name: LACTULOSE
LACTULOSE	LACTULOSE	PAI Holdings, LLC dba PAI Pharma	cbf0497c-9c8d-4dfa-bebd-64c589468401	2025-09-15	Warnings, Adverse reactions	Name fallback brand name: LACTULOSE generic name: LACTULOSE
Lactulose	LACTULOSE	Trifluent Pharma, Inc.	3eaf273a-b49d-2595-e063-6394a90a1cf6	2025-09-13	Warnings, Adverse reactions	Name fallback brand name: Lactulose generic name: LACTULOSE
LACTULOSE Crystalline	LACTULOSE	Cumberland Assured Products Inc.	59e75426-42ae-4904-941f-009181101a8a	2025-09-01	Warnings, Adverse reactions	Name fallback generic name: LACTULOSE
Lactulose	LACTULOSE	Sun Pharmaceutical Industries, Inc.	391cfd01-c1fa-41f9-abd7-d0abe9a27634	2025-08-04	Warnings, Adverse reactions	Name fallback brand name: Lactulose generic name: LACTULOSE
Enulose	LACTULOSE	Bryant Ranch Prepack	fa3aae7c-6f98-4fbb-85dc-32affe9874d5	2024-12-18	Warnings, Adverse reactions	Name fallback generic name: LACTULOSE
Generlac	LACTULOSE	Chartwell RX, LLC	35207edd-a5fe-4369-a079-7a8b0d2f2e91	2024-07-16	Warnings, Adverse reactions	Name fallback generic name: LACTULOSE
LACTULOSE	LACTULOSE	Proficient Rx LP	6bbabdc6-f6a8-4f67-a448-e452d1928deb	2024-06-01	Warnings, Adverse reactions	Name fallback brand name: LACTULOSE generic name: LACTULOSE
Lactulose	LACTULOSE	Fresenius Kabi Austria GmbH	a89835c9-8ce5-4627-8d7d-70ff175b2e07	2022-11-09	Adverse reactions	Name fallback brand name: Lactulose generic name: LACTULOSE
Constulose	LACTULOSE	Actavis Pharma, Inc.	461ec39f-eeb4-4460-9b5c-62367d47162b	2022-06-01	Warnings, Adverse reactions	Name fallback generic name: LACTULOSE