Application 090502

Type: ANDA
Sponsor: FRESENIUS KABI

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
A090502-001	LACTULOSE	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090502-001	AA

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA		2012-01-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA		2012-01-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA		2012-01-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA		2012-01-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090502-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	RS	2012-01-25	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090502-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090502-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090502-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090502-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090502-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090502-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090502-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090502-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090502-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090502-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090502-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090502-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090502-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090502-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090502-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090502-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090502-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090502-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090502-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090502-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090502-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090502-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090502-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090502-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090502-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090502-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090502-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090502-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090502-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090502-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090502-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090502-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090502-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090502-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090502-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090502-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090502-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090502-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090502-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090502-001	AA	1	`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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Enulose	LACTULOSE	Bryant Ranch Prepack	fa3aae7c-6f98-4fbb-85dc-32affe9874d5	2024-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090502 application number: ANDA090502 ndc (product): 63629-8800
Lactulose	LACTULOSE	Fresenius Kabi Austria GmbH	a89835c9-8ce5-4627-8d7d-70ff175b2e07	2022-11-09	Adverse reactions	Exact identifier application applno (ANDA): 090502 application number: ANDA090502 ndc (product): 18124-002
Enulose	LACTULOSE	Actavis Pharma, Inc.	00c42c5c-d19e-4130-aa08-a8bbd47d3e5b	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090502 application number: ANDA090502 ndc (product): 45963-438

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
18124-002	Lactulose	Lactulose	Fresenius Kabi Austria GmbH	ANDA	Current
18124-002	Lactulose	Lactulose	Fresenius Kabi Austria GmbH	ANDA	Current
18124-002	Lactulose	Lactulose	Fresenius Kabi Austria GmbH	ANDA	Current
45963-438	Enulose	Lactulose	Actavis Pharma, Inc.	ANDA	Current
45963-438	Enulose	Lactulose	Actavis Pharma, Inc.	ANDA	Current
63629-8800	Enulose	Lactulose	Bryant Ranch Prepack	ANDA	Current
63629-8800	Enulose	Lactulose	Bryant Ranch Prepack	ANDA	Current