Application 079220

Type: ANDA
Sponsor: NATCO PHARMA LTD

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
A079220-001	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
A079220-001	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	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079220-001	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	A079220-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079220-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079220-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079220-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079220-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079220-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079220-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079220-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079220-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079220-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079220-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079220-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079220-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079220-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079220-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079220-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079220-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079220-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079220-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079220-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079220-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079220-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079220-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079220-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079220-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079220-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079220-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079220-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079220-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079220-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079220-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079220-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079220-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079220-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079220-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079220-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079220-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079220-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079220-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079220-001	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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ANASTROZOLE	ANASTROZOLE	PD-Rx Pharmaceuticals, Inc.	5d4f90d4-e535-4681-a863-3d774a2064e6	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079220 application number: ANDA079220 ndc (product): 43063-383
ANASTROZOLE	ANASTROZOLE	Breckenridge Pharmaceutical, Inc.	ca9d4aff-ffdf-4a46-ad20-e47e5886a19e	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079220 application number: ANDA079220 ndc (product): 51991-620
ANASTROZOLE	ANASTROZOLE	NuCare Pharmaceuticals,Inc.	69be1c52-93db-e2c3-e053-2a91aa0af774	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079220 application number: ANDA079220 ndc (product): 68071-4038
ANASTROZOLE	ANASTROZOLE	AvPAK	94a46579-0d79-89c7-e053-2995a90a6467	2026-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079220 application number: ANDA079220 ndc (product): 50268-075
ANASTROZOLE	ANASTROZOLE	AvKARE	f40b925f-9f43-321d-e053-2a95a90aca8b	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079220 application number: ANDA079220
ANASTROZOLE	ANASTROZOLE	NuCare Pharmaceuticals, Inc.	362034e9-2830-19a5-e063-6394a90a8dfb	2025-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079220 application number: ANDA079220
ANASTROZOLE	ANASTROZOLE	NuCare Pharmaceuticals,Inc.	33f14d51-de4e-cbe4-e063-6294a90a964b	2025-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079220 application number: ANDA079220
ANASTROZOLE	ANASTROZOLE	A-S Medication Solutions	90d9dbb4-b1ba-431e-b588-1a1a04cf1444	2025-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079220 application number: ANDA079220 ndc (product): 50090-5002
ANASTROZOLE	ANASTROZOLE	Bryant Ranch Prepack	1d1d5818-1594-4f54-90a9-ae9a9afcdc67	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079220 application number: ANDA079220 ndc (product): 71335-1879
Anastrozole	ANASTROZOLE	Natco Pharma Limited	df55dc4c-9a53-4a37-a90f-c4e88d458b89	2020-10-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079220 application number: ANDA079220 ndc (product): 63850-0010

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16571-421	Anastrozole	Anastrozole	Rising Pharmaceuticals, Inc.	ANDA	Current
16571-421	Anastrozole	Anastrozole	Rising Pharmaceuticals, Inc.	ANDA	Current
21695-990	Anastrozole	Anastrozole	Rebel Distributors Corp	ANDA	Current
43063-383	ANASTROZOLE	ANASTROZOLE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-383	ANASTROZOLE	ANASTROZOLE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-383	ANASTROZOLE	ANASTROZOLE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-383	ANASTROZOLE	ANASTROZOLE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-383	ANASTROZOLE	ANASTROZOLE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-383	ANASTROZOLE	ANASTROZOLE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-383	ANASTROZOLE	ANASTROZOLE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-5002	ANASTROZOLE	ANASTROZOLE	A-S Medication Solutions	ANDA	Current
50090-5002	ANASTROZOLE	ANASTROZOLE	A-S Medication Solutions	ANDA	Current
50268-075	ANASTROZOLE	ANASTROZOLE	AvPAK	ANDA	Current
50268-075	ANASTROZOLE	ANASTROZOLE	AvPAK	ANDA	Current
51991-620	ANASTROZOLE	ANASTROZOLE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-620	ANASTROZOLE	ANASTROZOLE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-620	ANASTROZOLE	ANASTROZOLE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-620	ANASTROZOLE	ANASTROZOLE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-620	ANASTROZOLE	ANASTROZOLE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
63850-0010	Anastrozole	Anastrozole	Natco Pharma Limited	ANDA	Current
63850-0010	Anastrozole	Anastrozole	Natco Pharma Limited	ANDA	Current
63850-0010	Anastrozole	Anastrozole	Natco Pharma Limited	ANDA	Current
67877-171	Anastrozole	Anastrozole	Ascend Laboratories, LLC	ANDA	Current
67877-171	Anastrozole	Anastrozole	Ascend Laboratories, LLC	ANDA	Current
68071-4038	ANASTROZOLE	ANASTROZOLE	NuCare Pharmaceuticals,Inc.	ANDA	Current
71335-1879	ANASTROZOLE	ANASTROZOLE	Bryant Ranch Prepack	ANDA	Current
71335-1879	ANASTROZOLE	ANASTROZOLE	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9237	ORIG	2010-06-30