Application 215016

Type: ANDA
Sponsor: TORRENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SIROLIMUS	SIROLIMUS	SOLUTION;ORAL	1MG/ML	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
A215016-001	SIROLIMUS	SIROLIMUS	1MG/ML	SOLUTION / ORAL			2021-12-27

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.

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	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL		2021-12-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL		2021-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL		2021-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL		2021-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL		2021-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL		2021-12-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL		2021-12-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL		2021-12-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL		2021-12-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL		2021-12-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL		2021-12-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL		2021-12-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL		2021-12-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL		2021-12-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2021-12-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2021-12-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2021-12-27	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2021-12-27	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL		2021-12-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL		2021-12-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL		2021-12-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL		2021-12-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL		2021-12-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL		2021-12-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL		2021-12-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL		2021-12-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL		2021-12-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL		2021-12-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL		2021-12-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL		2021-12-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL		2021-12-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215016-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL		2021-12-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215016-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215016-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215016-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215016-001	AA	1	`bb7c543d1eb4…`

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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sirolimus	SIROLIMUS	REMEDYREPACK INC.	fc81cb86-61e1-4622-b2ce-cde263143aa0	2026-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sirolimus generic name: SIROLIMUS
sirolimus	SIROLIMUS	American Health Packaging	a71c205f-7acc-40e5-9eee-69daeb49a352	2026-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: sirolimus generic name: SIROLIMUS
FYARRO	SIROLIMUS	Aadi Bioscience, Inc.	0f9bb784-53e2-46f9-a65d-1c6c2a230eaf	2026-05-19	Warnings, Adverse reactions	Name fallback generic name: SIROLIMUS
sirolimus	SIROLIMUS	NORTHSTAR RX LLC	ad39eb60-1fa0-4722-8ba1-523194921c2a	2026-05-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: sirolimus generic name: SIROLIMUS
sirolimus	SIROLIMUS	Bryant Ranch Prepack	f9843d49-0e16-4427-9cea-9f66f32b97f7	2026-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: sirolimus generic name: SIROLIMUS
Sirolimus	SIROLIMUS	Mylan Pharmaceuticals Inc.	5908cd1a-fc5a-462f-99ed-1d8983e253c9	2026-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sirolimus generic name: SIROLIMUS
Sirolimus	SIROLIMUS	AvPAK	6a85ad01-8144-4d9c-e053-2991aa0a4f85	2026-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sirolimus generic name: SIROLIMUS
sirolimus	SIROLIMUS	Glenmark Pharmaceuticals Inc., USA	57fb4d90-3ccb-4a69-af1e-53be83f7a504	2026-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: sirolimus generic name: SIROLIMUS
Sirolimus	SIROLIMUS	Major Pharmaceuticals	1bef7d8f-524b-4218-8fef-6c3f3628d33e	2025-11-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sirolimus generic name: SIROLIMUS
Sirolimus	SIROLIMUS	Rising Pharma Holdings, Inc.	400da0a5-2a85-44ab-a2c5-bb9161750db3	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sirolimus generic name: SIROLIMUS
Sirolimus	SIROLIMUS	Apotex Corp	9f64692d-2a18-ffcb-c572-0f218a71ca67	2025-09-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sirolimus generic name: SIROLIMUS
Sirolimus	SIROLIMUS	Ascend Laboratories, LLC	cdc49844-3e77-41d3-8287-b16d0c4742c5	2025-09-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sirolimus generic name: SIROLIMUS
sirolimus	SIROLIMUS	Northstar Rx LLC	848b53ea-cdb6-45f8-bc70-8600d2dd6dce	2025-08-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: sirolimus generic name: SIROLIMUS
HYFTOR	SIROLIMUS	Nobelpharma America, LLC	edb3ea90-5adc-48ec-99f5-ab963e302f18	2025-08-22	Warnings, Adverse reactions	Name fallback generic name: SIROLIMUS
Sirolimus	SIROLIMUS	American Health Packaging	5df60452-2b16-4ce9-8c29-48798a59d718	2025-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sirolimus generic name: SIROLIMUS
sirolimus	SIROLIMUS	REMEDYREPACK INC.	9970e495-29c4-47b8-a3e9-c9b365abe400	2025-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: sirolimus generic name: SIROLIMUS
Sirolimus	SIROLIMUS	REMEDYREPACK INC.	74549ff2-74dc-449d-9a01-087260f9f8be	2025-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sirolimus generic name: SIROLIMUS
sirolimus	SIROLIMUS	REMEDYREPACK INC.	09f24e7a-0bea-4e02-b557-c60eb842d41a	2025-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: sirolimus generic name: SIROLIMUS
Sirolimus	SIROLIMUS	Mylan Pharmaceuticals Inc.	384cb547-55a4-47fc-a0a6-054c18a51b84	2025-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sirolimus generic name: SIROLIMUS
sirolimus	SIROLIMUS	Novadoz Pharmaceuticals LLC	580c1ec1-c1f5-45f6-89b7-3be25c07a0e5	2025-03-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: sirolimus generic name: SIROLIMUS

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13668-658	Sirolimus	Sirolimus	Torrent pharmaceuticals limited	ANDA	Current