Application 090568

Type: ANDA
Sponsor: ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ANASTROZOLE	ANASTROZOLE	TABLET;ORAL	1MG	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
A090568-001	ANASTROZOLE	ANASTROZOLE	1MG	TABLET / ORAL	AB		2010-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090568-001	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	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`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	A090568-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090568-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090568-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090568-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090568-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090568-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090568-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090568-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090568-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090568-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090568-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090568-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090568-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090568-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090568-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090568-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090568-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090568-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090568-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090568-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090568-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090568-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090568-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090568-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090568-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090568-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090568-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090568-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090568-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090568-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090568-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090568-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090568-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090568-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090568-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090568-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090568-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090568-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090568-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090568-001	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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anastrozole	ANASTROZOLE	PD-Rx Pharmaceuticals, Inc.	aabd8f88-2b52-4d43-8dc6-61605988c4dc	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090568 application number: ANDA090568 ndc (product): 72789-008
Anastrozole	ANASTROZOLE	Asclemed USA, Inc.	b964f555-25d2-47ad-8942-f195f062445c	2026-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090568 application number: ANDA090568 ndc (product): 76420-004
Anastrozole	ANASTROZOLE	Accord Healthcare Inc.	03586c40-eb32-45c5-beb7-6762a6b78790	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090568 application number: ANDA090568 ndc (product): 16729-035
Anastrozole	ANASTROZOLE	NuCare Pharmaceuticals,Inc.	e3b5fc92-9189-6944-e053-2a95a90a1c9f	2025-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090568 application number: ANDA090568 ndc (product): 68071-2791
ANASTROZOLE	ANASTROZOLE	Direct_Rx	f37db328-bb81-9df9-e053-2a95a90a6f43	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090568 application number: ANDA090568
Anastrozole	ANASTROZOLE	NuCare Pharmaceuticals,Inc.	5a2d5052-95ce-d103-e053-2991aa0aa4be	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090568 application number: ANDA090568 ndc (product): 68071-1682
Anastrozole	ANASTROZOLE	Bryant Ranch Prepack	19251d0b-279a-49f5-99b2-0e74d7cca479	2024-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090568 application number: ANDA090568 ndc (product): 63629-5269
Anastrozole	ANASTROZOLE	NuCare Pharmaceuticals,Inc.	a0acddf1-a973-bf37-e053-2995a90a0bd5	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090568 application number: ANDA090568 ndc (product): 68071-5203
Anastrozole	ANASTROZOLE	A-S Medication Solutions	03fb3108-1856-466d-bf88-0eac96139551	2024-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090568 application number: ANDA090568 ndc (product): 50090-2453
Anastrozole	ANASTROZOLE	NuCare Pharmaceuticals,Inc.	ef6c9f7c-a1b0-3fee-e053-2995a90ab2c4	2024-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090568 application number: ANDA090568 ndc (product): 68071-1543
Anastrozole	ANASTROZOLE	Proficient Rx LP	c7a36fd8-530e-4c63-97d5-0f80fab5880e	2023-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090568 application number: ANDA090568 ndc (product): 63187-080

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 45 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6195	Anastrozole	Anastrozole	Major Pharmaceuticals	ANDA	Current
0904-6195	Anastrozole	Anastrozole	Major Pharmaceuticals	ANDA	Current
16729-035	Anastrozole	Anastrozole	Accord Healthcare Inc.	ANDA	Current
16729-035	Anastrozole	Anastrozole	Accord Healthcare Inc.	ANDA	Current
16729-035	Anastrozole	Anastrozole	Accord Healthcare Inc.	ANDA	Current
42254-161	Anastrozole	Anastrozole	Rebel Distributors Corp	ANDA	Current
45865-909	Anastrozole	Anastrozole	medsource pharmaceuticals	ANDA	Current
50090-2453	Anastrozole	Anastrozole	A-S Medication Solutions	ANDA	Current
50090-2453	Anastrozole	Anastrozole	A-S Medication Solutions	ANDA	Current
50090-2453	Anastrozole	Anastrozole	A-S Medication Solutions	ANDA	Current
50090-2453	Anastrozole	Anastrozole	A-S Medication Solutions	ANDA	Current
51655-638	Anastrozole	Anastrozole	Northwind Pharmaceuticals, LLC	ANDA	Current
63187-080	Anastrozole	Anastrozole	Proficient Rx LP	ANDA	Current
63187-080	Anastrozole	Anastrozole	Proficient Rx LP	ANDA	Current
63187-080	Anastrozole	Anastrozole	Proficient Rx LP	ANDA	Current
63187-080	Anastrozole	Anastrozole	Proficient Rx LP	ANDA	Current
63187-080	Anastrozole	Anastrozole	Proficient Rx LP	ANDA	Current
63629-5269	Anastrozole	Anastrozole	Bryant Ranch Prepack	ANDA	Current
63629-5269	Anastrozole	Anastrozole	Bryant Ranch Prepack	ANDA	Current
63629-5269	Anastrozole	Anastrozole	Bryant Ranch Prepack	ANDA	Current
63629-5269	Anastrozole	Anastrozole	Bryant Ranch Prepack	ANDA	Current
66336-533	Anastrozole	Anastrozole	Dispensing Solutions, Inc.	ANDA	Current
68071-1543	Anastrozole	Anastrozole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1682	Anastrozole	Anastrozole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1682	Anastrozole	Anastrozole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2791	Anastrozole	Anastrozole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5203	Anastrozole	Anastrozole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5203	Anastrozole	Anastrozole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-6774	Anastrozole	Anastrozole	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-6774	Anastrozole	Anastrozole	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-6774	Anastrozole	Anastrozole	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-2420	Anastrozole	Anastrozole	REMEDYREPACK INC.	ANDA	Current
70518-2420	Anastrozole	Anastrozole	REMEDYREPACK INC.	ANDA	Current
70518-2420	Anastrozole	Anastrozole	REMEDYREPACK INC.	ANDA	Current
70518-2484	Anastrozole	Anastrozole	REMEDYREPACK INC.	ANDA	Current
70518-2484	Anastrozole	Anastrozole	REMEDYREPACK INC.	ANDA	Current
70934-488	Anastrozole	Anastrozole	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
72789-008	Anastrozole	Anastrozole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-008	Anastrozole	Anastrozole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-008	Anastrozole	Anastrozole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-008	Anastrozole	Anastrozole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-008	Anastrozole	Anastrozole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
76420-004	Anastrozole	Anastrozole	Asclemed USA, Inc.	ANDA	Current
76420-004	Anastrozole	Anastrozole	Asclemed USA, Inc.	ANDA	Current
76519-1224	ANASTROZOLE	ANASTROZOLE	H.J. Harkins Company, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9277	ORIG	2010-06-30