Application 020753

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AROMASIN	EXEMESTANE	TABLET;ORAL	25MG	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020753-001	AROMASIN	EXEMESTANE	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020753-001	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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020753-001	AROMASIN	25MG	TABLET / ORAL	AB	RLD, RS	1999-10-21	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	N020753-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020753-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020753-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020753-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020753-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020753-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020753-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020753-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020753-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020753-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020753-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020753-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020753-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020753-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020753-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020753-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020753-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020753-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020753-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020753-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020753-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020753-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020753-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020753-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020753-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020753-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020753-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020753-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020753-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020753-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020753-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020753-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020753-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020753-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020753-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020753-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020753-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020753-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020753-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020753-001	AB	1	`e64feba35796…`

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
EXEMESTANE	EXEMESTANE	Mylan Pharmaceuticals Inc.	69abd0ff-b200-4d1a-b14a-80e980a8e781	2025-12-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020753 application number: NDA020753 ndc (product): 59762-2858
Aromasin	EXEMESTANE	Pharmacia & Upjohn Company LLC	cf066b7a-032a-416c-8d40-15ba581423e3	2025-12-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020753 application number: NDA020753 ndc (product): 0009-7663

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0009-7663	Aromasin	exemestane	Pharmacia & Upjohn Company LLC	NDA	Current
0009-7663	Aromasin	exemestane	Pharmacia and Upjohn Company LLC	NDA	Current
0009-7663	Aromasin	exemestane	Pharmacia & Upjohn Company LLC	NDA	Current
0009-7663	Aromasin	exemestane	Pharmacia & Upjohn Company LLC	NDA	Current
59762-2858	EXEMESTANE	Exemestane	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2858	EXEMESTANE	Exemestane	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2858	EXEMESTANE	Exemestane	Greenstone LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80622	SUPPL	2024-12-18
80601	SUPPL	2024-12-17
69356	SUPPL	2021-11-18
69342	SUPPL	2021-11-18
54284	SUPPL	2018-05-22
54276	SUPPL	2018-05-21
13350	SUPPL	2016-07-27
25705	SUPPL	2016-07-26
35273	SUPPL	2014-05-06
25704	SUPPL	2014-05-06
13349	SUPPL	2014-05-06
3267	SUPPL	2014-05-06
13348	SUPPL	2013-02-20
3266	SUPPL	2013-02-20
25703	SUPPL	2011-03-28
25702	SUPPL	2011-03-28
13347	SUPPL	2011-03-28
13346	SUPPL	2011-03-28
13345	SUPPL	2011-03-28
3265	SUPPL	2011-03-28
24138	SUPPL	2009-01-02
25701	SUPPL	2008-12-30
3264	SUPPL	2005-10-11
13344	SUPPL	2005-10-07
25700	SUPPL	2004-09-29
13343	SUPPL	2004-09-29
20900	ORIG	2004-05-27
13342	SUPPL	2003-12-02
3263	SUPPL	2003-11-25
13341	ORIG	1999-10-21
3262	ORIG	1999-10-21