Application 201578

Type: ANDA
Sponsor: DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SIROLIMUS	SIROLIMUS	TABLET;ORAL	1MG	No	No
002	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A201578-001	SIROLIMUS	SIROLIMUS	1MG	TABLET / ORAL	AB		2014-10-27
A201578-002	SIROLIMUS	SIROLIMUS	2MG	TABLET / ORAL	AB		2014-10-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A201578-001	AB
A201578-002	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 · 84 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	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A201578-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201578-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201578-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201578-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201578-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201578-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201578-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201578-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201578-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201578-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201578-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201578-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201578-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201578-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201578-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201578-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201578-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201578-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201578-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201578-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201578-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201578-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201578-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201578-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201578-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201578-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201578-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201578-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201578-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201578-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201578-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201578-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201578-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201578-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201578-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201578-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201578-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201578-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201578-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201578-002	AB	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 1 · 4 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	Exact identifier application applno (ANDA): 201578 application number: ANDA201578
Sirolimus	SIROLIMUS	AvPAK	6a85ad01-8144-4d9c-e053-2991aa0a4f85	2026-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201578 application number: ANDA201578 ndc (product): 50268-718
Sirolimus	SIROLIMUS	American Health Packaging	5df60452-2b16-4ce9-8c29-48798a59d718	2025-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201578 application number: ANDA201578 ndc (product): 68084-915
Sirolimus	SIROLIMUS	Dr. Reddy's Laboratories Limited	2e6130e5-fa94-dcf8-605c-817bf396e93d	2023-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201578 application number: ANDA201578 ndc (product): 55111-654 ndc (product): 55111-653

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50268-718	Sirolimus	Sirolimus	AvPAK	ANDA	Current
50268-718	Sirolimus	Sirolimus	AvPAK	ANDA	Current
55111-653	Sirolimus	Sirolimus	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-653	Sirolimus	Sirolimus	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-653	Sirolimus	Sirolimus	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-653	Sirolimus	Sirolimus	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-654	Sirolimus	Sirolimus	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-654	Sirolimus	Sirolimus	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-654	Sirolimus	Sirolimus	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-654	Sirolimus	Sirolimus	Dr. Reddy's Laboratories Limited	ANDA	Current
68084-915	Sirolimus	Sirolimus	American Health Packaging	ANDA	Current
68084-915	Sirolimus	Sirolimus	American Health Packaging	ANDA	Current
68084-915	Sirolimus	Sirolimus	American Health Packaging	ANDA	Current
68084-915	Sirolimus	Sirolimus	American Health Packaging	ANDA	Current