Application 214753

Type: ANDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SIROLIMUS	SIROLIMUS	TABLET;ORAL	0.5MG	No	No
002	SIROLIMUS	SIROLIMUS	TABLET;ORAL	1MG	No	No
003	SIROLIMUS	SIROLIMUS	TABLET;ORAL	2MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214753-001	SIROLIMUS	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2021-03-12
A214753-002	SIROLIMUS	SIROLIMUS	1MG	TABLET / ORAL	AB	2021-03-12
A214753-003	SIROLIMUS	SIROLIMUS	2MG	TABLET / ORAL	AB	2021-03-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A214753-001	AB
A214753-002	AB
A214753-003	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 3 · 105 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
2026-08-18 06:07:40	2026-07	A214753-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2021-03-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214753-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2021-03-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214753-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2021-03-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214753-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2021-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214753-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2021-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214753-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2021-03-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214753-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2021-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214753-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2021-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214753-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2021-03-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214753-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2021-03-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214753-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2021-03-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214753-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2021-03-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214753-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2021-03-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214753-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2021-03-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214753-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2021-03-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214753-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2021-03-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214753-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2021-03-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214753-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2021-03-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214753-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2021-03-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214753-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2021-03-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214753-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2021-03-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214753-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2021-03-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214753-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2021-03-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214753-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2021-03-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214753-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2021-03-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214753-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2021-03-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214753-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2021-03-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214753-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2021-03-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214753-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2021-03-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214753-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2021-03-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214753-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2021-03-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214753-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2021-03-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214753-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2021-03-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214753-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2021-03-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214753-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2021-03-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214753-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2021-03-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214753-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2021-03-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214753-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2021-03-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214753-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2021-03-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214753-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2021-03-12	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 105 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A214753-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214753-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214753-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214753-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214753-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214753-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214753-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214753-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214753-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214753-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214753-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214753-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214753-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214753-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214753-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214753-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214753-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214753-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214753-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214753-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214753-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214753-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214753-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214753-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214753-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214753-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214753-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214753-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214753-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214753-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214753-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214753-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214753-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214753-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214753-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214753-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214753-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214753-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214753-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214753-001	AB	1	`1e350fbaab3a…`

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
Sirolimus	SIROLIMUS	Major Pharmaceuticals	1bef7d8f-524b-4218-8fef-6c3f3628d33e	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214753 application number: ANDA214753 ndc (product): 0904-7248
Sirolimus	SIROLIMUS	Ascend Laboratories, LLC	cdc49844-3e77-41d3-8287-b16d0c4742c5	2025-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214753 application number: ANDA214753 ndc (product): 67877-748 ndc (product): 67877-747 ndc (product): 67877-746
Sirolimus	SIROLIMUS	REMEDYREPACK INC.	74549ff2-74dc-449d-9a01-087260f9f8be	2025-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214753 application number: ANDA214753 ndc (product): 70518-3546

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
0904-7248	Sirolimus	Sirolimus	Major Pharmaceuticals	ANDA	Current
67877-746	Sirolimus	Sirolimus	Ascend Laboratories, LLC	ANDA	Current
67877-746	Sirolimus	Sirolimus	Ascend Laboratories, LLC	ANDA	Current
67877-747	Sirolimus	Sirolimus	Ascend Laboratories, LLC	ANDA	Current
67877-747	Sirolimus	Sirolimus	Ascend Laboratories, LLC	ANDA	Current
67877-748	Sirolimus	Sirolimus	Ascend Laboratories, LLC	ANDA	Current
67877-748	Sirolimus	Sirolimus	Ascend Laboratories, LLC	ANDA	Current
70518-3546	Sirolimus	Sirolimus	REMEDYREPACK INC.	ANDA	Current
70518-3547	Sirolimus	Sirolimus	REMEDYREPACK INC.	ANDA	Current