Application 202023

Type: ANDA
Sponsor: AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	TABLET;ORAL	EQ 25MG BASE	No	No
002	SILDENAFIL CITRATE	SILDENAFIL CITRATE	TABLET;ORAL	EQ 50MG BASE	No	No
003	SILDENAFIL CITRATE	SILDENAFIL CITRATE	TABLET;ORAL	EQ 100MG 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202023-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27
A202023-002	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27
A202023-003	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A202023-001	AB
A202023-002	AB
A202023-003	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 4 · 126 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	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A202023-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202023-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202023-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202023-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202023-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202023-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202023-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202023-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202023-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202023-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202023-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202023-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202023-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202023-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202023-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202023-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202023-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202023-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202023-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202023-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202023-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202023-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202023-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202023-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202023-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202023-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202023-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202023-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202023-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202023-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202023-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202023-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202023-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202023-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202023-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202023-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202023-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202023-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202023-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202023-001	AB	1	`1e350fbaab3a…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sildenafil	SILDENAFIL	Bryant Ranch Prepack	dfe4f616-b5de-458c-a97b-ab860e32320c	2026-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202023 application number: ANDA202023 ndc (product): 63629-7833
Sildenafil	SILDENAFIL	Amneal Pharmaceuticals NY LLC	a1c3a2a2-8cf5-41c3-9c86-54290570d916	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202023 application number: ANDA202023 ndc (product): 60219-1752 ndc (product): 60219-1751 ndc (product): 60219-1753
Sildenafil	SILDENAFIL	NuCare Pharmaceuticals,Inc.	f98d51a5-e3c8-2b6c-e053-6294a90ac146	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202023 application number: ANDA202023
Sildenafil	SILDENAFIL	Bryant Ranch Prepack	96ae6733-cef9-46cf-bf4e-5368201943bd	2024-05-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202023 application number: ANDA202023 ndc (product): 71335-0969

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4644	Sildenafil	Sildenafil	A-S Medication Solutions	ANDA	Current
50090-4644	Sildenafil	Sildenafil	A-S Medication Solutions	ANDA	Current
50090-4646	Sildenafil	Sildenafil	A-S Medication Solutions	ANDA	Current
50090-4646	Sildenafil	Sildenafil	A-S Medication Solutions	ANDA	Current
60219-1751	Sildenafil	Sildenafil	Amneal Pharmaceuticals LLC	ANDA	Current
60219-1751	Sildenafil	Sildenafil	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1751	Sildenafil	Sildenafil	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1751	Sildenafil	Sildenafil	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1752	Sildenafil	Sildenafil	Amneal Pharmaceuticals LLC	ANDA	Current
60219-1752	Sildenafil	Sildenafil	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1752	Sildenafil	Sildenafil	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1752	Sildenafil	Sildenafil	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1753	Sildenafil	Sildenafil	Amneal Pharmaceuticals LLC	ANDA	Current
60219-1753	Sildenafil	Sildenafil	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1753	Sildenafil	Sildenafil	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1753	Sildenafil	Sildenafil	Amneal Pharmaceuticals NY LLC	ANDA	Current
63629-7833	Sildenafil	Sildenafil	Bryant Ranch Prepack	ANDA	Current
63629-7833	Sildenafil	Sildenafil	Bryant Ranch Prepack	ANDA	Current
63629-7833	Sildenafil	Sildenafil	Bryant Ranch Prepack	ANDA	Current
68071-2898	Sildenafil	Sildenafil	NuCare Pharmaceuticals,Inc.	ANDA	Current
71335-0969	Sildenafil	Sildenafil	Bryant Ranch Prepack	ANDA	Current
71335-0969	Sildenafil	Sildenafil	Bryant Ranch Prepack	ANDA	Current
71335-0969	Sildenafil	Sildenafil	Bryant Ranch Prepack	ANDA	Current
73160-005	sildenafil citrate	sildenafil	CarePartners Pharmacy, LLC	ANDA	Current