Application 202025

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	TABLET;ORAL	EQ 20MG BASE	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
A202025-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB		2013-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202025-001	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	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`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	A202025-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202025-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202025-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202025-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202025-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202025-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202025-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202025-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202025-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202025-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202025-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202025-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202025-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202025-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202025-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202025-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202025-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202025-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202025-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202025-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202025-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202025-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202025-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202025-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202025-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202025-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202025-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202025-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202025-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202025-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202025-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202025-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202025-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202025-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202025-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202025-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202025-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202025-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202025-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202025-001	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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sildenafil	SILDENAFIL	A-S Medication Solutions	dc38f412-dca7-4b54-b14c-314e7a251ee6	2026-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202025 application number: ANDA202025 ndc (product): 50090-1766
Sildenafil	SILDENAFIL	Bryant Ranch Prepack	a636d3c7-af25-4148-8b4e-6f44deba700b	2026-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202025 application number: ANDA202025 ndc (product): 63629-5029
Sildenafil	SILDENAFIL	Amneal Pharmaceuticals LLC	187de471-3e79-44ed-b560-0f8b2d549f74	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202025 application number: ANDA202025 ndc (product): 65162-351
Sildenafil	SILDENAFIL	REMEDYREPACK INC.	f5113b5e-9087-4397-86bc-5ea10413c429	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202025 application number: ANDA202025
Sildenafil	SILDENAFIL	AvKARE	21c83ff3-c359-3269-e063-6394a90a57ee	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202025 application number: ANDA202025
Sildenafil	SILDENAFIL	Northwind Health Company, LLC	fa14cb6b-0fa8-0ba0-e053-6294a90afae3	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202025 application number: ANDA202025
Sildenafil	SILDENAFIL	AvPAK	e08de794-9b7e-aae6-9c89-a0c0d090cc76	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202025 application number: ANDA202025 ndc (product): 50268-717
Sildenafil	SILDENAFIL	Amneal Pharmaceuticals of New York LLC	a0b734f4-9347-484d-b307-d493ae50ee54	2024-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202025 application number: ANDA202025
Sildenafil	SILDENAFIL	Proficient Rx LP	38a5592a-c14a-40af-a19a-588cb11090ed	2020-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202025 application number: ANDA202025 ndc (product): 63187-789

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-1766	Sildenafil	Sildenafil	A-S Medication Solutions	ANDA	Current
50090-1766	Sildenafil	Sildenafil	A-S Medication Solutions	ANDA	Current
50090-1766	Sildenafil	Sildenafil	A-S Medication Solutions	ANDA	Current
50268-717	Sildenafil	Sildenafil	AvPAK	ANDA	Current
50268-717	Sildenafil	Sildenafil	AvPAK	ANDA	Current
63187-789	Sildenafil	Sildenafil	Proficient Rx LP	ANDA	Current
63187-789	Sildenafil	Sildenafil	Proficient Rx LP	ANDA	Current
63187-789	Sildenafil	Sildenafil	Proficient Rx LP	ANDA	Current
63629-5029	Sildenafil	Sildenafil	Bryant Ranch Prepack	ANDA	Current
63629-5029	Sildenafil	Sildenafil	Bryant Ranch Prepack	ANDA	Current
63629-5029	Sildenafil	Sildenafil	Bryant Ranch Prepack	ANDA	Current
65162-351	Sildenafil	Sildenafil	Amneal Pharmaceuticals LLC	ANDA	Current
65162-351	Sildenafil	Sildenafil	Amneal Pharmaceuticals LLC	ANDA	Current
65162-351	Sildenafil	Sildenafil	Amneal Pharmaceuticals LLC	ANDA	Current
65162-351	Sildenafil	Sildenafil	Amneal Pharmaceuticals LLC	ANDA	Current
68001-176	Sildenafil	Sildenafil	BluePoint Laboratories	ANDA	Current
68071-3329	Sildenafil	Sildenafil	NuCare Pharmaceuticals, Inc.	ANDA	Current
68084-869	Sildenafil	Sildenafil	American Health Packaging	ANDA	Current