Application 090732

Type: ANDA
Sponsor: NEOPHARMA

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 43.

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
A090732-001	ANASTROZOLE	ANASTROZOLE	1MG	TABLET / ORAL			2010-06-28

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 · 43 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	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090732-001	ANASTROZOLE	1MG	TABLET / ORAL		2010-06-28	`f41ea6bd6efb…`

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	A090732-001	AB	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A090732-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090732-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090732-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090732-001	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 2 of 2 · 40 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anastrozole	ANASTROZOLE TABLETS	Proficient Rx LP	2df2aa01-1fe7-477c-9a23-699879b0b918	2025-09-01	Warnings, Adverse reactions	Name fallback brand name: Anastrozole
Anastrozole	ANASTROZOLE	American Health Packaging	dface914-5135-4136-82f4-75429b496a35	2025-08-29	Warnings, Adverse reactions	Name fallback brand name: Anastrozole generic name: ANASTROZOLE
Anastrozole	ANASTROZOLE TABLETS	Upsher-Smith Laboratories, LLC	7e0bd2cc-d3cc-403f-a6b6-4597ccb2f685	2025-07-09	Warnings, Adverse reactions	Name fallback brand name: Anastrozole
Anastrozole	ANASTROZOLE	Aurobindo Pharma Limited	71f053c2-8d0d-41a1-8630-2d797eced799	2025-05-19	Warnings, Adverse reactions	Name fallback brand name: Anastrozole generic name: ANASTROZOLE
ANASTROZOLE	ANASTROZOLE	NuCare Pharmaceuticals,Inc.	33f14d51-de4e-cbe4-e063-6294a90a964b	2025-04-29	Warnings, Adverse reactions	Name fallback brand name: ANASTROZOLE generic name: ANASTROZOLE
ANASTROZOLE	ANASTROZOLE	A-S Medication Solutions	90d9dbb4-b1ba-431e-b588-1a1a04cf1444	2025-04-29	Warnings, Adverse reactions	Name fallback brand name: ANASTROZOLE generic name: ANASTROZOLE
Anastrozole	ANASTROZOLE	NuCare Pharmaceuticals,Inc.	e3b5fc92-9189-6944-e053-2a95a90a1c9f	2025-04-03	Warnings, Adverse reactions	Name fallback brand name: Anastrozole generic name: ANASTROZOLE
Anastrozole	ANASTROZOLE	PD-Rx Pharmaceuticals, Inc.	b023a9f2-1a99-4b40-a953-edac7e3a79bf	2025-02-19	Warnings, Adverse reactions	Name fallback brand name: Anastrozole generic name: ANASTROZOLE
Anastrozole	ANASTROZOLE	BluePoint Laboratories	3cd04ed6-7c5a-4c4a-9955-ee40839dfea0	2025-02-10	Warnings, Adverse reactions	Name fallback brand name: Anastrozole generic name: ANASTROZOLE
ANASTROZOLE	ANASTROZOLE	Direct_Rx	f37db328-bb81-9df9-e053-2a95a90a6f43	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: ANASTROZOLE generic name: ANASTROZOLE
Anastrozole	ANASTROZOLE	Teva Pharmaceuticals USA, Inc.	c58c7013-50a0-4734-8a78-38ff20a3e7eb	2025-01-14	Warnings, Adverse reactions	Name fallback brand name: Anastrozole generic name: ANASTROZOLE
Anastrozole	ANASTROZOLE	Zydus Pharmaceuticals USA Inc.	ca16f8de-d9a5-4c6c-957b-ae28497b67ac	2025-01-03	Warnings, Adverse reactions	Name fallback brand name: Anastrozole generic name: ANASTROZOLE
Anastrozole	ANASTROZOLE	NuCare Pharmaceuticals,Inc.	5a2d5052-95ce-d103-e053-2991aa0aa4be	2024-12-26	Warnings, Adverse reactions	Name fallback brand name: Anastrozole generic name: ANASTROZOLE
Anastrozole	ANASTROZOLE	Zydus Lifesciences Limited	965c4cb1-f6b8-47ac-bf13-c36639aa908f	2024-11-25		Name fallback brand name: Anastrozole generic name: ANASTROZOLE
Anastrozole	ANASTROZOLE	Bryant Ranch Prepack	19251d0b-279a-49f5-99b2-0e74d7cca479	2024-08-22	Warnings, Adverse reactions	Name fallback brand name: Anastrozole generic name: ANASTROZOLE
Anastrozole	ANASTROZOLE	NuCare Pharmaceuticals,Inc.	a0acddf1-a973-bf37-e053-2995a90a0bd5	2024-06-20	Warnings, Adverse reactions	Name fallback brand name: Anastrozole generic name: ANASTROZOLE
Anastrozole	ANASTROZOLE	A-S Medication Solutions	03fb3108-1856-466d-bf88-0eac96139551	2024-06-05	Warnings, Adverse reactions	Name fallback brand name: Anastrozole generic name: ANASTROZOLE
Anastrozole	ANASTROZOLE	NuCare Pharmaceuticals,Inc.	ef6c9f7c-a1b0-3fee-e053-2995a90ab2c4	2024-04-05	Warnings, Adverse reactions	Name fallback brand name: Anastrozole generic name: ANASTROZOLE
Anastrozole	ANASTROZOLE	Proficient Rx LP	c7a36fd8-530e-4c63-97d5-0f80fab5880e	2023-05-01	Warnings, Adverse reactions	Name fallback brand name: Anastrozole generic name: ANASTROZOLE
Anastrozole	ANASTROZOLE	Natco Pharma Limited	df55dc4c-9a53-4a37-a90f-c4e88d458b89	2020-10-19	Warnings, Adverse reactions	Name fallback brand name: Anastrozole generic name: ANASTROZOLE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31490	ORIG	2010-06-30