Application 208687

Type: ANDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AZATHIOPRINE	AZATHIOPRINE	TABLET;ORAL	25MG	No	No
002	AZATHIOPRINE	AZATHIOPRINE	TABLET;ORAL	50MG	No	No
003	AZATHIOPRINE	AZATHIOPRINE	TABLET;ORAL	75MG	No	No
004	AZATHIOPRINE	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
A208687-001	AZATHIOPRINE	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2020-03-27
A208687-002	AZATHIOPRINE	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2020-03-27
A208687-003	AZATHIOPRINE	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2020-03-27
A208687-004	AZATHIOPRINE	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2020-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208687-001	AB
A208687-002	AB
A208687-003	AB
A208687-004	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 4 · 148 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	A208687-001	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2020-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208687-002	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2020-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208687-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2020-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208687-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2020-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208687-001	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2020-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208687-002	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2020-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208687-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2020-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208687-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2020-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208687-001	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2020-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208687-002	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2020-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208687-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2020-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208687-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2020-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208687-001	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2020-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208687-002	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2020-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208687-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2020-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208687-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2020-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208687-001	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2020-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208687-002	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2020-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208687-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2020-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208687-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2020-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208687-001	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2020-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208687-002	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2020-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208687-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2020-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208687-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2020-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208687-001	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2020-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208687-002	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2020-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208687-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2020-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208687-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2020-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208687-001	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2020-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208687-002	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2020-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208687-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2020-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208687-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2020-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208687-001	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2020-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208687-002	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2020-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208687-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2020-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208687-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2020-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208687-001	AZATHIOPRINE	25MG	TABLET / ORAL	AB	2020-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208687-002	AZATHIOPRINE	50MG	TABLET / ORAL	AB	2020-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208687-003	AZATHIOPRINE	75MG	TABLET / ORAL	AB	2020-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208687-004	AZATHIOPRINE	100MG	TABLET / ORAL	AB	2020-03-27	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 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	A208687-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208687-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208687-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208687-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208687-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208687-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208687-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208687-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208687-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208687-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208687-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208687-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208687-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208687-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208687-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208687-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208687-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208687-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208687-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208687-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208687-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208687-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208687-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208687-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208687-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208687-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208687-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208687-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208687-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208687-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208687-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208687-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208687-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208687-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208687-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208687-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208687-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208687-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208687-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208687-004	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azathioprine	AZATHIOPRINE	NuCare Pharmaceuticals,Inc.	5116b22b-1460-5535-e063-6394a90acbe5	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208687 application number: ANDA208687
Azathioprine	AZATHIOPRINE	REMEDYREPACK INC.	f251f372-c881-483e-8035-c6a8a6bfb4e8	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208687 application number: ANDA208687 ndc (product): 70518-3544
Azathioprine	AZATHIOPRINE	Ascend Laboratories, LLC	bc6dc4bd-2121-4613-9d90-4a504010c98a	2025-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208687 application number: ANDA208687 ndc (product): 67877-493 ndc (product): 67877-495 ndc (product): 67877-494 ndc (product): 67877-492

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67877-492	Azathioprine	Azathioprine	Ascend Laboratories, LLC	ANDA	Current
67877-492	Azathioprine	Azathioprine	Ascend Laboratories, LLC	ANDA	Current
67877-493	Azathioprine	Azathioprine	Ascend Laboratories, LLC	ANDA	Current
67877-493	Azathioprine	Azathioprine	Ascend Laboratories, LLC	ANDA	Current
67877-494	Azathioprine	Azathioprine	Ascend Laboratories, LLC	ANDA	Current
67877-494	Azathioprine	Azathioprine	Ascend Laboratories, LLC	ANDA	Current
67877-495	Azathioprine	Azathioprine	Ascend Laboratories, LLC	ANDA	Current
67877-495	Azathioprine	Azathioprine	Ascend Laboratories, LLC	ANDA	Current
70518-3544	Azathioprine	Azathioprine	REMEDYREPACK INC.	ANDA	Current