Application 075252

Type: ANDA
Sponsor: AAIPHARMA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AZASAN	AZATHIOPRINE	TABLET;ORAL	50MG	No	No
002	AZASAN	AZATHIOPRINE	TABLET;ORAL	25MG	No	No
003	AZASAN	AZATHIOPRINE	TABLET;ORAL	75MG	No	No
004	AZASAN	AZATHIOPRINE	TABLET;ORAL	100MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075252-001	AZASAN	AZATHIOPRINE	50MG	TABLET / ORAL	AB	1999-06-07
A075252-002	AZASAN	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2003-02-03
A075252-003	AZASAN	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2003-02-03
A075252-004	AZASAN	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2003-02-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A075252-001	AB
A075252-002	AB
A075252-003	AB
A075252-004	AB

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 5 · 164 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	A075252-001	AZASAN	50MG	TABLET / ORAL	AB	1999-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075252-002	AZASAN	25MG	TABLET / ORAL	AB	2003-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075252-003	AZASAN	75MG	TABLET / ORAL	AB	2003-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075252-004	AZASAN	100MG	TABLET / ORAL	AB	2003-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075252-001	AZASAN	50MG	TABLET / ORAL	AB	1999-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075252-002	AZASAN	25MG	TABLET / ORAL	AB	2003-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075252-003	AZASAN	75MG	TABLET / ORAL	AB	2003-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075252-004	AZASAN	100MG	TABLET / ORAL	AB	2003-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075252-001	AZASAN	50MG	TABLET / ORAL	AB	1999-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075252-002	AZASAN	25MG	TABLET / ORAL	AB	2003-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075252-003	AZASAN	75MG	TABLET / ORAL	AB	2003-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075252-004	AZASAN	100MG	TABLET / ORAL	AB	2003-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075252-001	AZASAN	50MG	TABLET / ORAL	AB	1999-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075252-002	AZASAN	25MG	TABLET / ORAL	AB	2003-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075252-003	AZASAN	75MG	TABLET / ORAL	AB	2003-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075252-004	AZASAN	100MG	TABLET / ORAL	AB	2003-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075252-001	AZASAN	50MG	TABLET / ORAL	AB	1999-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075252-002	AZASAN	25MG	TABLET / ORAL	AB	2003-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075252-003	AZASAN	75MG	TABLET / ORAL	AB	2003-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075252-004	AZASAN	100MG	TABLET / ORAL	AB	2003-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075252-001	AZASAN	50MG	TABLET / ORAL	AB	1999-06-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075252-002	AZASAN	25MG	TABLET / ORAL	AB	2003-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075252-003	AZASAN	75MG	TABLET / ORAL	AB	2003-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075252-004	AZASAN	100MG	TABLET / ORAL	AB	2003-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075252-001	AZASAN	50MG	TABLET / ORAL	AB	1999-06-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075252-002	AZASAN	25MG	TABLET / ORAL	AB	2003-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075252-003	AZASAN	75MG	TABLET / ORAL	AB	2003-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075252-004	AZASAN	100MG	TABLET / ORAL	AB	2003-02-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075252-001	AZASAN	50MG	TABLET / ORAL	AB	1999-06-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075252-002	AZASAN	25MG	TABLET / ORAL	AB	2003-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075252-003	AZASAN	75MG	TABLET / ORAL	AB	2003-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075252-004	AZASAN	100MG	TABLET / ORAL	AB	2003-02-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075252-001	AZASAN	50MG	TABLET / ORAL	AB	1999-06-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075252-002	AZASAN	25MG	TABLET / ORAL	AB	2003-02-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075252-003	AZASAN	75MG	TABLET / ORAL	AB	2003-02-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075252-004	AZASAN	100MG	TABLET / ORAL	AB	2003-02-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075252-001	AZASAN	50MG	TABLET / ORAL	AB	1999-06-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075252-002	AZASAN	25MG	TABLET / ORAL	AB	2003-02-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075252-003	AZASAN	75MG	TABLET / ORAL	AB	2003-02-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075252-004	AZASAN	100MG	TABLET / ORAL	AB	2003-02-03	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A075252-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075252-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075252-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075252-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075252-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075252-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075252-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075252-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075252-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075252-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075252-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075252-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075252-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075252-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075252-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075252-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075252-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075252-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075252-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075252-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075252-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075252-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075252-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075252-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075252-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075252-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075252-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075252-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075252-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075252-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075252-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075252-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075252-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075252-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075252-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075252-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075252-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075252-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075252-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075252-004	AB	1	`d06236e962d9…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azathioprine	AZATHIOPRINE	Oceanside Pharmaceuticals	d72ede2c-1a9b-4717-80a7-b76a6a499936	2025-09-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075252 application number: ANDA075252
Azasan	AZATHIOPRINE	Salix Pharmaceuticals	9050af7a-19c6-4670-937a-9445605de995	2025-09-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075252 application number: ANDA075252 ndc (product): 65649-231 ndc (product): 65649-241
Azathioprine	AZATHIOPRINE	Golden State Medical Supply, Inc.	8429e025-b79d-dae7-e053-2a91aa0a7fe5	2025-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075252 application number: ANDA075252 ndc (product): 51407-182
Azathioprine	AZATHIOPRINE	Glenmark Pharmaceuticals, Inc	ceab8e8b-d022-4d0c-a552-cc5782446248	2024-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075252 application number: ANDA075252 ndc (product): 68462-502

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 41 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51407-182	Azathioprine	Azathioprine	Golden State Medical Supply Inc	ANDA	Current
51407-182	Azathioprine	Azathioprine	Golden State Medical Supply, Inc.	ANDA	Current
51407-182	Azathioprine	Azathioprine	Golden State Medical Supply	ANDA	Current
51407-182	Azathioprine	Azathioprine	Golden State Medical Supply	ANDA	Current
51407-182	Azathioprine	Azathioprine	Golden State Medical Supply Inc.	ANDA	Current
65649-231	Azasan	Azathioprine	Salix Pharmaceuticals Inc.	ANDA	Current
65649-231	Azasan	Azathioprine	Salix Pharmaceuticals	ANDA	Current
65649-231	Azasan	Azathioprine	Salix Pharmaceuticals	ANDA	Current
65649-231	Azasan	Azathioprine	Salix Pharmaceuticals Inc.	ANDA	Current
65649-231	Azasan	Azathioprine	Salix Pharmaceuticals	ANDA	Current
65649-231	Azasan	Azathioprine	Salix Pharmaceuticals	ANDA	Current
65649-231	Azasan	Azathioprine	Salix Pharmaceuticals	ANDA	Current
65649-231	Azasan	Azathioprine	Salix Pharmaceuticals	ANDA	Current
65649-231	Azasan	Azathioprine	Salix Pharmaceuticals Inc.	ANDA	Current
65649-231	Azasan	Azathioprine	Salix Pharmaceuticals	ANDA	Current
65649-241	Azasan	Azathioprine	Salix Pharmaceuticals Inc.	ANDA	Current
65649-241	Azasan	Azathioprine	Salix Pharmaceuticals	ANDA	Current
65649-241	Azasan	Azathioprine	Salix Pharmaceuticals	ANDA	Current
65649-241	Azasan	Azathioprine	Salix Pharmaceuticals Inc.	ANDA	Current
65649-241	Azasan	Azathioprine	Salix Pharmaceuticals	ANDA	Current
65649-241	Azasan	Azathioprine	Salix Pharmaceuticals	ANDA	Current
65649-241	Azasan	Azathioprine	Salix Pharmaceuticals	ANDA	Current
65649-241	Azasan	Azathioprine	Salix Pharmaceuticals	ANDA	Current
65649-241	Azasan	Azathioprine	Salix Pharmaceuticals Inc.	ANDA	Current
65649-241	Azasan	Azathioprine	Salix Pharmaceuticals	ANDA	Current
68462-502	Azathioprine	Azathioprine	Glenmark Pharmaceuticals, Inc	ANDA	Current
68462-502	Azathioprine	Azathioprine	Glenmark Pharmaceuticals, Inc	ANDA	Current
68462-502	Azathioprine	Azathioprine	Glenmark Pharmaceuticals, Inc	ANDA	Current
68462-502	Azathioprine	Azathioprine	Glenmark Pharmaceuticals, Inc	ANDA	Current
68462-502	Azathioprine	Azathioprine	Glenmark Pharmaceuticals, Inc	ANDA	Current
68462-502	Azathioprine	Azathioprine	Glenmark Pharmaceuticals, Inc	ANDA	Current
68462-502	Azathioprine	Azathioprine	Glenmark Pharmaceuticals, Inc	ANDA	Current
68462-502	Azathioprine	Azathioprine	Glenmark Pharmaceuticals, Inc	ANDA	Current
68462-502	Azathioprine	Azathioprine	Glenmark Pharmaceuticals, Inc	ANDA	Current
68462-502	Azathioprine	Azathioprine	Glenmark Pharmaceuticals, Inc	ANDA	Current
68462-502	Azathioprine	Azathioprine	Glenmark Pharmaceuticals, Inc	ANDA	Current
68462-502	Azathioprine	Azathioprine	Glenmark Pharmaceuticals, Inc	ANDA	Current
68462-502	Azathioprine	Azathioprine	Glenmark Pharmaceuticals, Inc	ANDA	Current
68462-502	Azathioprine	Azathioprine	Glenmark Pharmaceuticals, Inc	ANDA	Current
68462-502	Azathioprine	Azathioprine	Glenmark Pharmaceuticals, Inc	ANDA	Current
71610-306	Azathioprine	Azathioprine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8583	ORIG	1999-06-07