Application 206662

Type: ANDA
Sponsor: GLENMARK PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TACROLIMUS	TACROLIMUS	CAPSULE;ORAL	EQ 0.5MG BASE	No	No
002	TACROLIMUS	TACROLIMUS	CAPSULE;ORAL	EQ 1MG BASE	No	No
003	TACROLIMUS	TACROLIMUS	CAPSULE;ORAL	EQ 5MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A206662-001	TACROLIMUS	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10
A206662-002	TACROLIMUS	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10
A206662-003	TACROLIMUS	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206662-001	AB
A206662-002	AB
A206662-003	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 · 108 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
2026-02-19 14:30 UTC	2026-02	A206662-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206662-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206662-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206662-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206662-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206662-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206662-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206662-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206662-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206662-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206662-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206662-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206662-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206662-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206662-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206662-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206662-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206662-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206662-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206662-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206662-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206662-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206662-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206662-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206662-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206662-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206662-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206662-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206662-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206662-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206662-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206662-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206662-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206662-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206662-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206662-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206662-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206662-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206662-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206662-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206662-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206662-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206662-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206662-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206662-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206662-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206662-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206662-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206662-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206662-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206662-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206662-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206662-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206662-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206662-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206662-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206662-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206662-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206662-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206662-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206662-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206662-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206662-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206662-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206662-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206662-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206662-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206662-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206662-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206662-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206662-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206662-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206662-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206662-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206662-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206662-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206662-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206662-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206662-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206662-001	AB	1	`8072bd15b7f6…`

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
tacrolimus	TACROLIMUS	A-S Medication Solutions	3519febc-c9df-4559-b07a-92f8b0c7e770	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206662 application number: ANDA206662 ndc (product): 50090-5581
tacrolimus	TACROLIMUS	NORTHSTAR RX LLC	875f4962-557e-4e12-ad7b-cb5fb6f2a65f	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206662 application number: ANDA206662 ndc (product): 16714-098 ndc (product): 16714-100 ndc (product): 16714-099
tacrolimus	TACROLIMUS	Glenmark Pharmaceuticals Inc., USA	4b310c6b-e035-4e44-9573-4001d58b2ad5	2026-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206662 application number: ANDA206662 ndc (product): 68462-685 ndc (product): 68462-686 ndc (product): 68462-687

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-098	tacrolimus	tacrolimus	NORTHSTAR RX LLC	ANDA	Current
16714-099	tacrolimus	tacrolimus	NORTHSTAR RX LLC	ANDA	Current
16714-100	tacrolimus	tacrolimus	NORTHSTAR RX LLC	ANDA	Current
50090-5581	tacrolimus	tacrolimus	A-S Medication Solutions	ANDA	Current
68462-685	tacrolimus	tacrolimus	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-685	tacrolimus	tacrolimus	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-685	tacrolimus	tacrolimus	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-686	tacrolimus	tacrolimus	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-686	tacrolimus	tacrolimus	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-686	tacrolimus	tacrolimus	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-687	tacrolimus	tacrolimus	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-687	tacrolimus	tacrolimus	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-687	tacrolimus	tacrolimus	Glenmark Pharmaceuticals Inc., USA	ANDA	Current