Application 074712

Type: ANDA
Sponsor: CUMBERLAND PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LACTULOSE	LACTULOSE	FOR SOLUTION;ORAL	10GM/PACKET	No	Yes
002	LACTULOSE	LACTULOSE	FOR SOLUTION;ORAL	20GM/PACKET	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074712-001	LACTULOSE	LACTULOSE	10GM/PACKET	FOR SOLUTION / ORAL	AA	RS	1997-12-10
A074712-002	LACTULOSE	LACTULOSE	20GM/PACKET	FOR SOLUTION / ORAL	AA	RS	1997-12-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A074712-001	AA
A074712-002	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 3 · 82 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	A074712-001	LACTULOSE	10GM/PACKET	FOR SOLUTION / ORAL	AA	RS	1997-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074712-002	LACTULOSE	20GM/PACKET	FOR SOLUTION / ORAL	AA	RS	1997-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074712-001	LACTULOSE	10GM/PACKET	FOR SOLUTION / ORAL	AA	RS	1997-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074712-002	LACTULOSE	20GM/PACKET	FOR SOLUTION / ORAL	AA	RS	1997-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074712-001	LACTULOSE	10GM/PACKET	FOR SOLUTION / ORAL	AA	RS	1997-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074712-002	LACTULOSE	20GM/PACKET	FOR SOLUTION / ORAL	AA	RS	1997-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074712-001	LACTULOSE	10GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074712-002	LACTULOSE	20GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074712-001	LACTULOSE	10GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074712-002	LACTULOSE	20GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074712-001	LACTULOSE	10GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074712-002	LACTULOSE	20GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074712-001	LACTULOSE	10GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074712-002	LACTULOSE	20GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074712-001	LACTULOSE	10GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074712-002	LACTULOSE	20GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074712-001	LACTULOSE	10GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074712-002	LACTULOSE	20GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074712-001	LACTULOSE	10GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074712-002	LACTULOSE	20GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074712-001	LACTULOSE	10GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074712-002	LACTULOSE	20GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074712-001	LACTULOSE	10GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074712-002	LACTULOSE	20GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074712-001	LACTULOSE	10GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074712-002	LACTULOSE	20GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074712-001	LACTULOSE	10GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074712-002	LACTULOSE	20GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074712-001	LACTULOSE	10GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074712-002	LACTULOSE	20GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074712-001	LACTULOSE	10GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074712-002	LACTULOSE	20GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074712-001	LACTULOSE	10GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074712-002	LACTULOSE	20GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074712-001	LACTULOSE	10GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074712-002	LACTULOSE	20GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074712-001	LACTULOSE	10GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074712-002	LACTULOSE	20GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074712-001	LACTULOSE	10GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074712-002	LACTULOSE	20GM/PACKET	FOR SOLUTION / ORAL		RS	1997-12-10	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074712-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074712-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074712-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074712-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074712-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074712-002	AA	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A074712-001	AA	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A074712-002	AA	1	`a50c72e98297…`

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
Lactulose	LACTULOSE	Foxland Pharmaceuticals, Inc.	3363bdbd-f0d1-45b3-8193-7fdb0a310cc2	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074712 application number: ANDA074712 ndc (product): 69067-010
LACTULOSE Crystalline	LACTULOSE	Cumberland Assured Products Inc.	59e75426-42ae-4904-941f-009181101a8a	2025-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074712 application number: ANDA074712
KRISTALOSE	LACTULOSE	Cumberland Pharmaceuticals Inc.	535dd1ea-b567-49f7-9a84-8ea91e78c466	2018-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074712 application number: ANDA074712 ndc (product): 66220-719 ndc (product): 66220-729

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
66220-719	Kristalose	lactulose	Cumberland Pharmaceuticals Inc.	ANDA	Current
66220-719	KRISTALOSE	lactulose	Cumberland Pharmaceuticals Inc.	ANDA	Current
66220-729	Kristalose	lactulose	Cumberland Pharmaceuticals Inc.	ANDA	Current
66220-729	KRISTALOSE	lactulose	Cumberland Pharmaceuticals Inc.	ANDA	Current
69067-010	Lactulose	Lactulose	Foxland Pharmaceuticals, Inc.	ANDA	Current
69067-010	Lactulose	Lactulose	Foxland Pharmaceuticals, Inc.	ANDA	Current
69067-010	Lactulose	Lactulose	Foxland Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42861	ORIG	2011-12-14