Application 090934

Type: ANDA
Sponsor: ACCORD HLTHCARE

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 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
A090934-001	LETROZOLE	LETROZOLE	2.5MG	TABLET / ORAL	AB		2011-06-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090934-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`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	A090934-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090934-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090934-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090934-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090934-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090934-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090934-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090934-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090934-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090934-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090934-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090934-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090934-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090934-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090934-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090934-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090934-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090934-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090934-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090934-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090934-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090934-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090934-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090934-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090934-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090934-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090934-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090934-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090934-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090934-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090934-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090934-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090934-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090934-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090934-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090934-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090934-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090934-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090934-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090934-001	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Letrozole	LETROZOLE	A-S Medication Solutions	065cc89f-3a3f-4d78-b9f6-1c32a77ceb1c	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090934 application number: ANDA090934 ndc (product): 50090-3474
Letrozole	LETROZOLE	Bryant Ranch Prepack	26dcb6ee-74d8-4804-b151-79a41484979b	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090934 application number: ANDA090934 ndc (product): 63629-7819
Letrozole	LETROZOLE	Accord Healthcare, Inc.	c391fe11-fd47-4a35-af6d-c823ab7b8838	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090934 application number: ANDA090934 ndc (product): 16729-034
Letrozole	LETROZOLE	ATLANTIC BIOLOGICALS CORP.	c10bf97f-f9cf-468a-8a1f-7637f41022e4	2025-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090934 application number: ANDA090934 ndc (product): 17856-0032
Letrozole	LETROZOLE	NuCare Pharmaceuticals,Inc.	a707ec4b-8d26-55c2-e053-2a95a90a2e07	2024-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090934 application number: ANDA090934 ndc (product): 68071-5264
Letrozole	LETROZOLE	NuCare Pharmaceuticals,Inc.	1b408ba8-05f7-1cf1-e063-6394a90a42bc	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090934 application number: ANDA090934

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16729-034	Letrozole	letrozole	Accord Healthcare, Inc.	ANDA	Current
16729-034	Letrozole	letrozole	Accord Healthcare, Inc.	ANDA	Current
16729-034	Letrozole	letrozole	Accord Healthcare, Inc.	ANDA	Current
16729-034	Letrozole	letrozole	Accord Healthcare, Inc.	ANDA	Current
17856-0032	Letrozole	letrozole	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
50090-3474	Letrozole	letrozole	A-S Medication Solutions	ANDA	Current
50090-3474	Letrozole	letrozole	A-S Medication Solutions	ANDA	Current
63629-7819	Letrozole	letrozole	Bryant Ranch Prepack	ANDA	Current
63629-7819	Letrozole	letrozole	Bryant Ranch Prepack	ANDA	Current
63629-7819	Letrozole	letrozole	Bryant Ranch Prepack	ANDA	Current
68071-5264	Letrozole	letrozole	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-1869	Letrozole	letrozole	REMEDYREPACK INC.	ANDA	Current
70518-1869	Letrozole	letrozole	REMEDYREPACK INC.	ANDA	Current