Application 201676

Type: ANDA
Sponsor: ZYDUS PHARMS

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	0.5MG	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
A201676-001	SIROLIMUS	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15
A201676-002	SIROLIMUS	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15
A201676-003	SIROLIMUS	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201676-001	AB
A201676-002	AB
A201676-003	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 · 90 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	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201676-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201676-003	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201676-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201676-003	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201676-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201676-003	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201676-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201676-003	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201676-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201676-003	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201676-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201676-003	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201676-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201676-003	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201676-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201676-003	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201676-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201676-003	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201676-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201676-003	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201676-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201676-003	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201676-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201676-003	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201676-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201676-003	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 90 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	A201676-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201676-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201676-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201676-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201676-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201676-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201676-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201676-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201676-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201676-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201676-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201676-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201676-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201676-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201676-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201676-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201676-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201676-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201676-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201676-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201676-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201676-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201676-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201676-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201676-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201676-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201676-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201676-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201676-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201676-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201676-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201676-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201676-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201676-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201676-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201676-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201676-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201676-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201676-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201676-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
sirolimus	SIROLIMUS	American Health Packaging	a71c205f-7acc-40e5-9eee-69daeb49a352	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201676 application number: ANDA201676
sirolimus	SIROLIMUS	REMEDYREPACK INC.	09f24e7a-0bea-4e02-b557-c60eb842d41a	2025-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201676 application number: ANDA201676
sirolimus	SIROLIMUS	Zydus Lifesciences Limited	82562b68-224d-482a-b399-a89b81d5eb31	2023-09-27		Exact identifier application applno (ANDA): 201676 application number: ANDA201676 ndc (product): 65841-771
sirolimus	SIROLIMUS	Zydus Pharmaceuticals USA Inc.	ec473170-47f1-4a5c-b4d9-ac36406ed241	2023-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201676 application number: ANDA201676 ndc (product): 68382-520

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65841-771	sirolimus	sirolimus	Zydus Lifesciences Limited	ANDA	Current
65841-771	sirolimus	sirolimus	Cadila Healthcare Limited	ANDA	Current
65841-771	sirolimus	sirolimus	Cadila Healthcare Limited	ANDA	Current
65841-771	sirolimus	sirolimus	Cadila Healthcare Limited	ANDA	Current
68084-956	Sirolimus	Sirolimus	American Health Packaging	ANDA	Current
68084-956	Sirolimus	Sirolimus	American Health Packaging	ANDA	Current
68382-520	sirolimus	sirolimus	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-520	sirolimus	sirolimus	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-520	sirolimus	sirolimus	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-520	sirolimus	sirolimus	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-520	sirolimus	sirolimus	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current