Application 090802

Type: ANDA
Sponsor: PANACEA BIOTEC 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 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
A090802-001	TACROLIMUS	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28
A090802-002	TACROLIMUS	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2012-09-28
A090802-003	TACROLIMUS	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2012-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090802-001	AB
A090802-002	AB
A090802-003	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 4 · 126 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	A090802-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090802-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2012-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090802-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090802-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090802-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2012-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090802-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090802-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090802-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2012-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090802-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090802-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090802-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2012-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090802-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090802-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090802-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2012-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090802-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090802-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090802-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2012-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090802-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090802-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090802-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2012-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090802-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090802-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090802-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2012-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090802-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090802-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090802-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2012-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090802-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090802-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090802-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2012-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090802-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090802-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090802-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2012-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090802-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090802-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090802-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2012-09-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090802-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090802-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090802-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2012-09-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090802-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090802-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A090802-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090802-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090802-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090802-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090802-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090802-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090802-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090802-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090802-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090802-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090802-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090802-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090802-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090802-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090802-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090802-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090802-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090802-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090802-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090802-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090802-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090802-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090802-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090802-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090802-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090802-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090802-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090802-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090802-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090802-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090802-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090802-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090802-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090802-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090802-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090802-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090802-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090802-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090802-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090802-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tacrolimus	TACROLIMUS	Jubilant Cadista Pharmaceuticals Inc.	651bd506-96b0-43e5-a4dd-db03bf9154c9	2026-03-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090802 application number: ANDA090802
Tacrolimus	TACROLIMUS	Panacea Biotec Limited	bd9fea26-0236-d437-c7df-4b7636210875	2024-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090802 application number: ANDA090802 ndc (product): 43817-421 ndc (product): 43817-423 ndc (product): 43817-422

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43817-421	Tacrolimus	Tacrolimus	Panacea Biotec Ltd	ANDA	Current
43817-421	Tacrolimus	Tacrolimus	Panacea Biotec Limited	ANDA	Current
43817-422	Tacrolimus	Tacrolimus	Panacea Biotec Ltd	ANDA	Current
43817-422	Tacrolimus	Tacrolimus	Panacea Biotec Limited	ANDA	Current
43817-423	Tacrolimus	Tacrolimus	Panacea Biotec Ltd	ANDA	Current
43817-423	Tacrolimus	Tacrolimus	Panacea Biotec Limited	ANDA	Current
62175-380	Tacrolimus	Tacrolimus	Kremers Urban Pharmaceuticals Inc.	ANDA	Current
62175-381	Tacrolimus	Tacrolimus	Kremers Urban Pharmaceuticals Inc.	ANDA	Current
62175-382	Tacrolimus	Tacrolimus	Kremers Urban Pharmaceuticals Inc.	ANDA	Current
69452-153	Tacrolimus	Tacrolimus	BionPharma Inc.,	ANDA	Current
69452-153	Tacrolimus	Tacrolimus	BionPharma Inc.,	ANDA	Current
69452-153	Tacrolimus	Tacrolimus	BionPharma Inc.,	ANDA	Current
69452-154	Tacrolimus	Tacrolimus	BionPharma Inc.,	ANDA	Current
69452-154	Tacrolimus	Tacrolimus	BionPharma Inc.,	ANDA	Current
69452-154	Tacrolimus	Tacrolimus	BionPharma Inc.,	ANDA	Current
69452-155	Tacrolimus	Tacrolimus	BionPharma Inc.,	ANDA	Current
69452-155	Tacrolimus	Tacrolimus	BionPharma Inc.,	ANDA	Current
69452-155	Tacrolimus	Tacrolimus	BionPharma Inc.,	ANDA	Current