Application 208691

Type: ANDA
Sponsor: GLENMARK PHARMS 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
A208691-001	SIROLIMUS	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16
A208691-002	SIROLIMUS	SIROLIMUS	1MG	TABLET / ORAL	AB	2020-10-16
A208691-003	SIROLIMUS	SIROLIMUS	2MG	TABLET / ORAL	AB	2020-10-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208691-001	AB
A208691-002	AB
A208691-003	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 · 111 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	A208691-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208691-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2020-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208691-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2020-10-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208691-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208691-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2020-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208691-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2020-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208691-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208691-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2020-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208691-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2020-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208691-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208691-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2020-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208691-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2020-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208691-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208691-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2020-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208691-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2020-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208691-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208691-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2020-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208691-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2020-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208691-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208691-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2020-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208691-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2020-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208691-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208691-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2020-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208691-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2020-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208691-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208691-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2020-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208691-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2020-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208691-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208691-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2020-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208691-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2020-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208691-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208691-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2020-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208691-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2020-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208691-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208691-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2020-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208691-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2020-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208691-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208691-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2020-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208691-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2020-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208691-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 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	A208691-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208691-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208691-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208691-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208691-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208691-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208691-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208691-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208691-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208691-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208691-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208691-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208691-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208691-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208691-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208691-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208691-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208691-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208691-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208691-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208691-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208691-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208691-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208691-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208691-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208691-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208691-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208691-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208691-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208691-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208691-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208691-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208691-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208691-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208691-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208691-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208691-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208691-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208691-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208691-001	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	NORTHSTAR RX LLC	ad39eb60-1fa0-4722-8ba1-523194921c2a	2026-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208691 application number: ANDA208691 ndc (product): 16714-189 ndc (product): 16714-188 ndc (product): 16714-187
sirolimus	SIROLIMUS	Glenmark Pharmaceuticals Inc., USA	57fb4d90-3ccb-4a69-af1e-53be83f7a504	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208691 application number: ANDA208691 ndc (product): 68462-683 ndc (product): 68462-682 ndc (product): 68462-684
sirolimus	SIROLIMUS	REMEDYREPACK INC.	9970e495-29c4-47b8-a3e9-c9b365abe400	2025-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208691 application number: ANDA208691

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
0904-7147	sirolimus	sirolimus	Major Pharmaceuticals	ANDA	Current
0904-7147	sirolimus	sirolimus	Major Pharmaceuticals	ANDA	Current
16714-187	sirolimus	sirolimus	NORTHSTAR RX LLC	ANDA	Current
16714-187	sirolimus	sirolimus	NORTHSTAR RX LLC	ANDA	Current
16714-188	sirolimus	sirolimus	NORTHSTAR RX LLC	ANDA	Current
16714-188	sirolimus	sirolimus	NORTHSTAR RX LLC	ANDA	Current
16714-189	sirolimus	sirolimus	NORTHSTAR RX LLC	ANDA	Current
16714-189	sirolimus	sirolimus	NORTHSTAR RX LLC	ANDA	Current
68462-682	sirolimus	sirolimus	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-682	sirolimus	sirolimus	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-683	sirolimus	sirolimus	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-683	sirolimus	sirolimus	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-684	sirolimus	sirolimus	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-684	sirolimus	sirolimus	Glenmark Pharmaceuticals Inc., USA	ANDA	Current