Application 090789

Type: ANDA
Sponsor: VINTAGE PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LETROZOLE	LETROZOLE	TABLET;ORAL	2.5MG	No	No

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

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
A090789-001	LETROZOLE	LETROZOLE	2.5MG	TABLET / ORAL			2011-06-03

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 · 41 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	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090789-001	LETROZOLE	2.5MG	TABLET / ORAL		2011-06-03	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A090789-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A090789-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090789-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090789-001	AB	1	`ea99ee380514…`

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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LETROZOLE	LETROZOLE	Breckenridge Pharmaceutical, Inc.	63e54b62-a30d-4a56-9215-75e7a0b0bf02	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: LETROZOLE generic name: LETROZOLE
Letrozole	LETROZOLE	Carnegie Pharmaceuticals LLC	cb1da0ac-8db1-4482-824d-430511d1b7a0	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: Letrozole generic name: LETROZOLE
LETROZOLE	LETROZOLE	A-S Medication Solutions	3baa3912-3e64-473b-8ec6-8557aa7907c2	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: LETROZOLE generic name: LETROZOLE
Letrozole	LETROZOLE	A-S Medication Solutions	065cc89f-3a3f-4d78-b9f6-1c32a77ceb1c	2026-06-22	Warnings, Adverse reactions	Name fallback brand name: Letrozole generic name: LETROZOLE
Femara	LETROZOLE	Novartis Pharmaceuticals Corporation	82b77d74-085f-45ac-a7dd-1f5c038bf406	2026-06-11	Warnings, Adverse reactions	Name fallback generic name: LETROZOLE
Letrozole	LETROZOLE TABLETS	Golden State Medical Supply, Inc.	32d7dd83-a3ef-41fe-e063-6394a90ae62a	2026-04-23	Warnings, Adverse reactions	Name fallback brand name: Letrozole
Letrozole	LETROZOLE	Bryant Ranch Prepack	26dcb6ee-74d8-4804-b151-79a41484979b	2026-04-03	Warnings, Adverse reactions	Name fallback brand name: Letrozole generic name: LETROZOLE
Letrozole	LETROZOLE TABLETS	Upsher-Smith Laboratories, LLC	2d1f18f0-2c77-407c-b702-2d1b07f92510	2026-03-19	Warnings, Adverse reactions	Name fallback brand name: Letrozole
Letrozole	LETROZOLE	Accord Healthcare, Inc.	c391fe11-fd47-4a35-af6d-c823ab7b8838	2026-02-09	Warnings, Adverse reactions	Name fallback brand name: Letrozole generic name: LETROZOLE
LETROZOLE	LETROZOLE	AvPAK	93f317f1-96d1-498e-e053-2995a90ac60d	2026-01-20	Warnings, Adverse reactions	Name fallback brand name: LETROZOLE generic name: LETROZOLE
Letrozole	LETROZOLE TABLETS	Yiling Pharmaceutical, Inc.	7b00e08c-9a1c-09e0-e053-2a91aa0a7638	2025-12-29	Warnings, Adverse reactions	Name fallback brand name: Letrozole
LETROZOLE	LETROZOLE	Chartwell RX, LLC	fa2d40a5-3504-44ef-8f5c-aa4c06308074	2025-12-08	Warnings, Adverse reactions	Name fallback brand name: LETROZOLE generic name: LETROZOLE
Letrozole	LETROZOLE	AvKARE	1524730f-e37d-478c-1956-b113b3ca42a8	2025-11-19	Warnings, Adverse reactions	Name fallback brand name: Letrozole generic name: LETROZOLE
Letrozole	LETROZOLE TABLETS	Avet Pharmaceuticals Inc.	fe0e4d4b-436d-a36d-e053-6294a90a973d	2025-09-30	Warnings, Adverse reactions	Name fallback brand name: Letrozole
Letrozole	LETROZOLE	ATLANTIC BIOLOGICALS CORP.	c10bf97f-f9cf-468a-8a1f-7637f41022e4	2025-06-24	Warnings, Adverse reactions	Name fallback brand name: Letrozole generic name: LETROZOLE
Letrozole	LETROZOLE	Aurobindo Pharma Limited	ff7325d2-3383-4ff9-a187-9350e3538640	2025-03-28	Warnings, Adverse reactions	Name fallback brand name: Letrozole generic name: LETROZOLE
Letrozole	LETROZOLE TABLETS	Bryant Ranch Prepack	6fd92634-c9c5-457e-808c-a4614e8db7db	2025-01-31	Warnings, Adverse reactions	Name fallback brand name: Letrozole
Letrozole	LETROZOLE	NuCare Pharmaceuticals,Inc.	a707ec4b-8d26-55c2-e053-2a95a90a2e07	2024-12-30	Warnings, Adverse reactions	Name fallback brand name: Letrozole generic name: LETROZOLE
Letrozole	LETROZOLE	Teva Pharmaceuticals USA, Inc.	8ebda73d-82a3-4b17-8a81-a1f258003d32	2024-12-30	Warnings, Adverse reactions	Name fallback brand name: Letrozole generic name: LETROZOLE
Letrozole	LETROZOLE	NuCare Pharmaceuticals,Inc.	1b408ba8-05f7-1cf1-e063-6394a90a42bc	2024-06-19	Warnings, Adverse reactions	Name fallback brand name: Letrozole generic name: LETROZOLE