Application 205775

Type: ANDA
Sponsor: PAR PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EVEROLIMUS	EVEROLIMUS	TABLET;ORAL	0.25MG	No	No
002	EVEROLIMUS	EVEROLIMUS	TABLET;ORAL	0.5MG	No	No
003	EVEROLIMUS	EVEROLIMUS	TABLET;ORAL	0.75MG	No	No
004	EVEROLIMUS	EVEROLIMUS	TABLET;ORAL	1MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A205775-001	EVEROLIMUS	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-10-18
A205775-002	EVEROLIMUS	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-10-18
A205775-003	EVEROLIMUS	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-10-18
A205775-004	EVEROLIMUS	EVEROLIMUS	1MG	TABLET / ORAL	AB	2021-10-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205775-001	AB
A205775-002	AB
A205775-003	AB
A205775-004	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
2026-09-14 22:38:34	2026-08	A205775-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205775-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205775-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205775-004	EVEROLIMUS	1MG	TABLET / ORAL	AB	2021-10-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205775-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205775-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205775-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205775-004	EVEROLIMUS	1MG	TABLET / ORAL	AB	2021-10-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205775-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205775-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205775-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205775-004	EVEROLIMUS	1MG	TABLET / ORAL	AB	2021-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205775-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205775-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205775-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205775-004	EVEROLIMUS	1MG	TABLET / ORAL	AB	2021-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205775-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205775-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205775-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205775-004	EVEROLIMUS	1MG	TABLET / ORAL	AB	2021-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205775-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205775-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205775-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205775-004	EVEROLIMUS	1MG	TABLET / ORAL	AB	2021-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205775-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205775-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205775-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205775-004	EVEROLIMUS	1MG	TABLET / ORAL	AB	2021-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205775-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205775-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205775-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205775-004	EVEROLIMUS	1MG	TABLET / ORAL	AB	2021-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205775-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205775-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205775-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205775-004	EVEROLIMUS	1MG	TABLET / ORAL	AB	2021-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205775-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205775-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205775-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205775-004	EVEROLIMUS	1MG	TABLET / ORAL	AB	2021-10-18	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 140 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A205775-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205775-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205775-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205775-004	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205775-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205775-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205775-003	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205775-004	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205775-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A205775-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A205775-003	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A205775-004	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205775-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A205775-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A205775-003	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A205775-004	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205775-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205775-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205775-003	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205775-004	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205775-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205775-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205775-003	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205775-004	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205775-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205775-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205775-003	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205775-004	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205775-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205775-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205775-003	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205775-004	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205775-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A205775-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A205775-003	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A205775-004	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205775-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A205775-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A205775-003	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A205775-004	AB	1	`3bdfa0b2c4d7…`

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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Everolimus	EVEROLIMUS	Hikma Pharmaceuticals USA Inc.	5aaf2fb7-93f6-40d6-941a-9583a3794ce7	2026-08-14	Warnings, Adverse reactions	Name fallback brand name: Everolimus generic name: EVEROLIMUS
Everolimus	EVEROLIMUS	i3 Pharmaceuticals, LLC	be5da0fd-8fd4-4f84-a307-f270048d503c	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Everolimus generic name: EVEROLIMUS
Everolimus	EVEROLIMUS TABLETS	Breckenridge Pharmaceutical, Inc.	c7bb6ba1-9a7f-43f5-b058-ef26d4b59221	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Everolimus
Everolimus	EVEROLIMUS	Biocon Pharma Inc.	5b809dfe-c076-07c5-207e-178c3f0d32d3	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Everolimus generic name: EVEROLIMUS
EVEROLIMUS	EVEROLIMUS	Amneal Pharmaceuticals NY LLC	6f1ae129-c21e-4c25-84c1-a6757d9a7eb2	2026-06-16	Warnings, Adverse reactions	Name fallback brand name: EVEROLIMUS generic name: EVEROLIMUS
TORPENZ	EVEROLIMUS	Upsher-Smith Laboratories, LLC	4c0075dd-a0a8-4dc4-be32-1be8383fbbdc	2026-06-10	Warnings, Adverse reactions	Name fallback generic name: EVEROLIMUS
Afinitor	EVEROLIMUS	Novartis Pharmaceuticals Corporation	2150f73a-179b-4afc-b8ce-67c85cc72f04	2026-06-01	Warnings, Adverse reactions	Name fallback generic name: EVEROLIMUS
Yulithira	EVEROLIMUS	CivicaScript, LLC	5e325efa-8ae6-4dac-b59b-d7c74c73186c	2026-03-31	Warnings, Adverse reactions	Name fallback generic name: EVEROLIMUS
everolimus	EVEROLIMUS	Novugen Pharma (USA) LLC.	67e62e26-448d-46ec-b5a1-00dc1b5e26c6	2026-03-10	Warnings, Adverse reactions	Name fallback brand name: everolimus generic name: EVEROLIMUS
everolimus	EVEROLIMUS	Aurobindo Pharma Limited	43ef3c29-0e25-4fdd-aea1-06a20af9bbab	2026-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: everolimus generic name: EVEROLIMUS
Everolimus	EVEROLIMUS	Ascend Laboratories, LLC	2693c497-a70b-4d00-b6db-602c872e5bed	2025-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Everolimus generic name: EVEROLIMUS
Everolimus	EVEROLIMUS	Natco Pharma Limited	d44998bb-5deb-4ee7-a0a5-979fe3f49557	2025-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Everolimus generic name: EVEROLIMUS
Everolimus	EVEROLIMUS	Breckenridge Pharmaceutical, Inc.	01f7b5fb-be0d-4adf-acd2-6899018de966	2025-09-05	Warnings, Adverse reactions	Name fallback brand name: Everolimus generic name: EVEROLIMUS
Everolimus	EVEROLIMUS	Biocon Pharma Inc.	435da284-ef0e-ca90-e0db-bab9382922e0	2025-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Everolimus generic name: EVEROLIMUS
EVEROLIMUS	EVEROLIMUS	Biocon Pharma Inc.	5fb55800-f322-6bb6-9dde-622925ef28bd	2025-03-21	Warnings, Adverse reactions	Name fallback brand name: EVEROLIMUS generic name: EVEROLIMUS
Everolimus	EVEROLIMUS	Hikma Pharmaceuticals USA Inc.	cf2dd54b-7a1d-4401-9a01-75e68235e433	2024-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Everolimus generic name: EVEROLIMUS
EVEROLIMUS	EVEROLIMUS	NorthStar RxLLC	5cfca904-b75c-5a39-8cb9-b99bb421bceb	2024-08-02	Warnings, Adverse reactions	Name fallback brand name: EVEROLIMUS generic name: EVEROLIMUS
Everolimus	EVEROLIMUS	Natco Pharma Limited	e3dbbc24-7e55-4069-a305-e2cded2db641	2023-06-08	Warnings, Adverse reactions	Name fallback brand name: Everolimus generic name: EVEROLIMUS

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
49884-158	Everolimus	Everolimus	Par Pharmaceutical, Inc.	ANDA	Current
49884-158	Everolimus	Everolimus	Par Pharmaceutical, Inc.	ANDA	Current
49884-159	Everolimus	Everolimus	Par Pharmaceutical, Inc.	ANDA	Current
49884-159	Everolimus	Everolimus	Par Pharmaceutical, Inc.	ANDA	Current
49884-160	Everolimus	Everolimus	Par Pharmaceutical, Inc.	ANDA	Current
49884-160	Everolimus	Everolimus	Par Pharmaceutical, Inc.	ANDA	Current
49884-283	Everolimus	Everolimus	Par Pharmaceutical, Inc.	ANDA	Current
49884-283	Everolimus	Everolimus	Par Pharmaceutical, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69684	ORIG	2021-12-20