Application 214182

Type: ANDA
Sponsor: BIOCON PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EVEROLIMUS	EVEROLIMUS	TABLET;ORAL	2.5MG	No	No
002	EVEROLIMUS	EVEROLIMUS	TABLET;ORAL	5MG	No	No
003	EVEROLIMUS	EVEROLIMUS	TABLET;ORAL	7.5MG	No	No
004	EVEROLIMUS	EVEROLIMUS	TABLET;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214182-001	EVEROLIMUS	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-02-11
A214182-002	EVEROLIMUS	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-02-11
A214182-003	EVEROLIMUS	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-02-11
A214182-004	EVEROLIMUS	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-02-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A214182-001	AB
A214182-002	AB
A214182-003	AB
A214182-004	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 · 140 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	A214182-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214182-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214182-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214182-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-02-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214182-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214182-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214182-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214182-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214182-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214182-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214182-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214182-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214182-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214182-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214182-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214182-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214182-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214182-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214182-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214182-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214182-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214182-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214182-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214182-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214182-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214182-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214182-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214182-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214182-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214182-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214182-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214182-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214182-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214182-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214182-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214182-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214182-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214182-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214182-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214182-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-02-11	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 136 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	A214182-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214182-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214182-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214182-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214182-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214182-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214182-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214182-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214182-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214182-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214182-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214182-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214182-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214182-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214182-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214182-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214182-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214182-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214182-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214182-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214182-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214182-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214182-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214182-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214182-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214182-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214182-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214182-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214182-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214182-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214182-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214182-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214182-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214182-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214182-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214182-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214182-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214182-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214182-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214182-004	AB	1	`d8e5a09893c0…`

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
TORPENZ	EVEROLIMUS	Upsher-Smith Laboratories, LLC	4c0075dd-a0a8-4dc4-be32-1be8383fbbdc	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214182 application number: ANDA214182
EVEROLIMUS	EVEROLIMUS	Biocon Pharma Inc.	5fb55800-f322-6bb6-9dde-622925ef28bd	2025-03-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214182 application number: ANDA214182 ndc (product): 70377-010 ndc (product): 70377-011 ndc (product): 70377-013 ndc (product): 70377-012
EVEROLIMUS	EVEROLIMUS	NorthStar RxLLC	5cfca904-b75c-5a39-8cb9-b99bb421bceb	2024-08-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214182 application number: ANDA214182

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70377-010	EVEROLIMUS	everolimus	Biocon Pharma Inc.	ANDA	Current
70377-010	EVEROLIMUS	everolimus	Biocon Pharma Inc.	ANDA	Current
70377-011	EVEROLIMUS	everolimus	Biocon Pharma Inc.	ANDA	Current
70377-011	EVEROLIMUS	everolimus	Biocon Pharma Inc.	ANDA	Current
70377-012	EVEROLIMUS	everolimus	Biocon Pharma Inc.	ANDA	Current
70377-012	EVEROLIMUS	everolimus	Biocon Pharma Inc.	ANDA	Current
70377-013	EVEROLIMUS	everolimus	Biocon Pharma Inc.	ANDA	Current
70377-013	EVEROLIMUS	everolimus	Biocon Pharma Inc.	ANDA	Current