Application 211406

Type: ANDA
Sponsor: APOTEX

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 43.

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
A211406-001	SIROLIMUS	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA		2019-10-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211406-001	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211406-001	SIROLIMUS	1MG/ML	SOLUTION / ORAL	AA	2019-10-22	`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
2026-09-14 22:38:34	2026-08	A211406-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211406-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211406-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211406-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211406-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211406-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211406-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211406-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211406-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211406-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211406-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211406-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211406-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211406-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211406-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211406-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211406-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211406-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211406-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211406-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211406-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211406-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211406-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211406-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211406-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211406-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211406-001	AA	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211406-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211406-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211406-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211406-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211406-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211406-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211406-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211406-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211406-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211406-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211406-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211406-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211406-001	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 2 · 22 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
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	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.	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	Novadoz Pharmaceuticals LLC	580c1ec1-c1f5-45f6-89b7-3be25c07a0e5	2025-03-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: sirolimus generic name: SIROLIMUS
SIROLIMUS	SIROLIMUS	Camber Pharmaceuticals, Inc.	80269e86-3b04-44d0-9bff-7e7129e8ccb3	2024-11-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SIROLIMUS generic name: SIROLIMUS
Sirolimus	SIROLIMUS	VistaPharm, LLC	19880f51-badb-4846-a02a-592a210690ab	2024-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sirolimus generic name: SIROLIMUS
Sirolimus	SIROLIMUS	Dr. Reddy's Laboratories Limited	2e6130e5-fa94-dcf8-605c-817bf396e93d	2023-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sirolimus generic name: SIROLIMUS
sirolimus	SIROLIMUS	Zydus Lifesciences Limited	82562b68-224d-482a-b399-a89b81d5eb31	2023-09-27		Name fallback brand name: sirolimus generic name: SIROLIMUS

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60505-6197	Sirolimus	SIROLIMUS	Apotex Corp	ANDA	Current
60505-6197	Sirolimus	SIROLIMUS	Apotex Corp	ANDA	Current
60505-6197	Sirolimus	SIROLIMUS	Apotex Corp	ANDA	Current