Application 074623

Type: ANDA
Sponsor: PHARM ASSOC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LACTULOSE	LACTULOSE	SOLUTION;ORAL	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
A074623-001	LACTULOSE	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074623-001	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	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`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	A074623-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074623-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074623-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074623-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074623-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074623-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074623-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074623-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074623-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074623-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074623-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074623-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074623-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074623-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074623-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074623-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074623-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074623-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074623-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074623-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074623-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074623-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074623-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074623-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074623-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074623-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074623-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074623-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074623-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074623-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074623-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074623-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074623-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074623-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074623-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074623-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074623-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074623-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074623-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074623-001	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LACTULOSE	LACTULOSE	Cardinal Health 107, LLC	3cf3ff7c-67e7-42a9-8ebb-bd6c53937dd7	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074623 application number: ANDA074623 ndc (product): 55154-9448
LACTULOSE	LACTULOSE	Atlantic Biologicals Corp.	3fb6e908-893c-5a57-e063-6294a90a1bfc	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074623 application number: ANDA074623
LACTULOSE	LACTULOSE	PAI Holdings, LLC dba PAI Pharma	0f19e4ed-c90a-4330-a7fa-bf911aa98f09	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074623 application number: ANDA074623 ndc (product): 0121-0577 ndc (product): 0121-4577 ndc (product): 0121-1154
LACTULOSE	LACTULOSE	PAI Holdings, LLC dba PAI Pharma	cbf0497c-9c8d-4dfa-bebd-64c589468401	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074623 application number: ANDA074623 ndc (product): 0121-1746 ndc (product): 0121-0873
LACTULOSE	LACTULOSE	Proficient Rx LP	6bbabdc6-f6a8-4f67-a448-e452d1928deb	2024-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074623 application number: ANDA074623

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0121-0577	LACTULOSE	LACTULOSE	Pharmaceutical Associates	ANDA	Current
0121-0577	LACTULOSE	LACTULOSE	Pharmaceutical Associates, Inc,	ANDA	Current
0121-0577	LACTULOSE	LACTULOSE	Pharmaceutical Associates, Inc,	ANDA	Current
0121-0577	LACTULOSE	LACTULOSE	Pharmaceutical Associates, Inc,	ANDA	Current
0121-0577	LACTULOSE	LACTULOSE	Pharmaceutical Associates, Inc,	ANDA	Current
0121-0577	LACTULOSE	LACTULOSE	Pharmaceutical Associates, Inc,	ANDA	Current
0121-0577	LACTULOSE	LACTULOSE	Pharmaceutical Associates, Inc,	ANDA	Current
0121-0873	LACTULOSE	Lactulose	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0873	LACTULOSE	Lactulose	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0873	LACTULOSE	Lactulose	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0873	LACTULOSE	Lactulose	Pharmaceutical Associates, Inc.	ANDA	Current
0121-1154	LACTULOSE	LACTULOSE	Pharmaceutical Associates	ANDA	Current
0121-1154	LACTULOSE	LACTULOSE	Pharmaceutical Associates, Inc,	ANDA	Current
0121-1154	LACTULOSE	LACTULOSE	Pharmaceutical Associates, Inc,	ANDA	Current
0121-1154	LACTULOSE	LACTULOSE	Pharmaceutical Associates, Inc,	ANDA	Current
0121-1154	LACTULOSE	LACTULOSE	Pharmaceutical Associates, Inc,	ANDA	Current
0121-1154	LACTULOSE	LACTULOSE	Pharmaceutical Associates, Inc,	ANDA	Current
0121-1154	LACTULOSE	LACTULOSE	Pharmaceutical Associates, Inc,	ANDA	Current
0121-1746	LACTULOSE	LACTULOSE	Pharmaceutical Associates, Inc.	ANDA	Current
0121-1746	LACTULOSE	LACTULOSE	Pharmaceutical Associates, Inc.	ANDA	Current
0121-1746	LACTULOSE	LACTULOSE	Pharmaceutical Associates, Inc.	ANDA	Current
0121-1746	LACTULOSE	LACTULOSE	Pharmaceutical Associates, Inc.	ANDA	Current
0121-4577	LACTULOSE	LACTULOSE	Pharmaceutical Associates	ANDA	Current
0121-4577	LACTULOSE	LACTULOSE	Pharmaceutical Associates, Inc,	ANDA	Current
0121-4577	LACTULOSE	LACTULOSE	Pharmaceutical Associates, Inc,	ANDA	Current
0121-4577	LACTULOSE	LACTULOSE	Pharmaceutical Associates, Inc,	ANDA	Current
0121-4577	LACTULOSE	LACTULOSE	Pharmaceutical Associates, Inc,	ANDA	Current
0121-4577	LACTULOSE	LACTULOSE	Pharmaceutical Associates, Inc,	ANDA	Current
0121-4577	LACTULOSE	LACTULOSE	Pharmaceutical Associates, Inc,	ANDA	Current
0527-5120	LACTULOSE	LACTULOSE	Lannett Company, Inc.	ANDA	Current
0527-5120	LACTULOSE	LACTULOSE	Lannett Company, Inc.	ANDA	Current
0527-5120	LACTULOSE	LACTULOSE	Lannett Company, Inc.	ANDA	Current
0527-5120	LACTULOSE	LACTULOSE	Lannett Company, Inc.	ANDA	Current
21695-997	Lactulose	lactulose	Rebel Distributors Corp	ANDA	Current
49999-800	Lactulose	lactulose	Quality Care Products, LLC	ANDA	Current
55154-5775	LACTULOSE	LACTULOSE	Cardinal Health	ANDA	Current
55154-5775	LACTULOSE	LACTULOSE	Cardinal Health	ANDA	Current
55154-5775	LACTULOSE	LACTULOSE	Cardinal Health	ANDA	Current
55154-9448	LACTULOSE	LACTULOSE	Cardinal Health	ANDA	Current
55154-9448	LACTULOSE	LACTULOSE	Cardinal Health	ANDA	Current
55154-9448	LACTULOSE	LACTULOSE	Cardinal Health	ANDA	Current
55154-9448	LACTULOSE	LACTULOSE	Cardinal Health	ANDA	Current
55700-892	LACTULOSE	Lactulose	Quality Care Products, LLC	ANDA	Current
68071-1562	LACTULOSE	LACTULOSE	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-1562	LACTULOSE	LACTULOSE	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-1562	LACTULOSE	LACTULOSE	NuCare Pharmaceuticals, Inc.	ANDA	Current