Application 206401

Type: ANDA
Sponsor: AJANTA PHARMA LTD

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 1.

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
A206401-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12
A206401-002	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-10-12
A206401-003	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-10-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206401-001	AB
A206401-002	AB
A206401-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A206401-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206401-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206401-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206401-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206401-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206401-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206401-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206401-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206401-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206401-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206401-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206401-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206401-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206401-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206401-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206401-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206401-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206401-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206401-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206401-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206401-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206401-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206401-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206401-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206401-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206401-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206401-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206401-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206401-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206401-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-10-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206401-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206401-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-10-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206401-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-10-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206401-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206401-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-10-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206401-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-10-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206401-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206401-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-10-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206401-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-10-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206401-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206401-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206401-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206401-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206401-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206401-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206401-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206401-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206401-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206401-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206401-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206401-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206401-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206401-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206401-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206401-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206401-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206401-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206401-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206401-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206401-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206401-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206401-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206401-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206401-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206401-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206401-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206401-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206401-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206401-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206401-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206401-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206401-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206401-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206401-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206401-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206401-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206401-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206401-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206401-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206401-001	AB	1	`8072bd15b7f6…`

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sildenafil Citrate	SILDENAFIL	Bryant Ranch Prepack	824dcd79-bc82-4b3a-8028-3c1bca1a7a0a	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206401 application number: ANDA206401 ndc (product): 71335-1437
Sildenafil Citrate	SILDENAFIL	NuCare Pharmaceuticals,Inc.	fbe75c2c-0aff-9ade-e053-6394a90a1ea4	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206401 application number: ANDA206401
Sildenafil Citrate	SILDENAFIL	Quallent Pharmaceuticals Health LLC	41b67fd2-3d9a-49d6-88b8-285044b98dc1	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206401 application number: ANDA206401
Sildenafil Citrate	SILDENAFIL	Ajanta Pharma USA Inc.	2ccc6fa6-f8ae-4191-806f-a887244e516a	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206401 application number: ANDA206401 ndc (product): 27241-068 ndc (product): 27241-069 ndc (product): 27241-067
Sildenafil Citrate	SILDENAFIL	Preferred Pharmaceuticals Inc.	878b4c44-cddc-42cb-b9b5-911451ad1530	2025-09-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206401 application number: ANDA206401 ndc (product): 68788-8301
Sildenafil Citrate	SILDENAFIL	NuCare Pharmaceuticals,Inc.	155c7549-b7d6-0c06-e063-6294a90ac65c	2025-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206401 application number: ANDA206401
Sildenafil Citrate	SILDENAFIL	NuCare Pharmaceuticals, Inc.	1d614710-708e-f11c-e063-6394a90a05a5	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206401 application number: ANDA206401
Sildenafil Citrate	SILDENAFIL CITRATE	NuCare Pharmaceuticals, Inc.	20ead8ca-7cec-2d80-e063-6394a90af548	2024-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206401 application number: ANDA206401
Sildenafil Citrate	SILDENAFIL	Advanced Rx of Tennessee, LLC	1ceb575b-2687-0456-e063-6394a90aa88a	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206401 application number: ANDA206401
Sildenafil Citrate	SILDENAFIL	NuCare Pharmaceuticals,Inc.	1b1ab00d-de9c-4614-e063-6394a90afcde	2024-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206401 application number: ANDA206401
Sildenafil Citrate	SILDENAFIL	NuCare Pharmaceuticals,Inc.	0bb3eb8d-05cd-b4cd-e063-6294a90a94bb	2024-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206401 application number: ANDA206401
Sildenafil Citrate	SILDENAFIL	A-S Medication Solutions	bf1a22a2-6a69-46c9-933d-e474e88637e9	2023-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206401 application number: ANDA206401 ndc (product): 50090-5906
Sildenafil Citrate	SILDENAFIL	Proficient Rx LP	b9b1d6ee-da42-4ef2-ab93-cd36d7f34150	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206401 application number: ANDA206401
Sildenafil Citrate	SILDENAFIL	Asclemed USA, Inc.	0500a861-359f-4e12-beb5-0cac8cd6ae1c	2023-05-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206401 application number: ANDA206401

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
27241-067	Sildenafil Citrate	Sildenafil	Ajanta Pharma Limited	ANDA	Current
27241-067	Sildenafil Citrate	Sildenafil	Ajanta Pharma USA Inc.	ANDA	Current
27241-067	Sildenafil Citrate	Sildenafil	Ajanta Pharma Limited	ANDA	Current
27241-068	Sildenafil Citrate	Sildenafil	Ajanta Pharma Limited	ANDA	Current
27241-068	Sildenafil Citrate	Sildenafil	Ajanta Pharma USA Inc.	ANDA	Current
27241-068	Sildenafil Citrate	Sildenafil	Ajanta Pharma Limited	ANDA	Current
27241-069	Sildenafil Citrate	Sildenafil	Ajanta Pharma Limited	ANDA	Current
27241-069	Sildenafil Citrate	Sildenafil	Ajanta Pharma USA Inc.	ANDA	Current
27241-069	Sildenafil Citrate	Sildenafil	Ajanta Pharma Limited	ANDA	Current
50090-5906	Sildenafil Citrate	Sildenafil	A-S Medication Solutions	ANDA	Current
68788-8301	Sildenafil Citrate	Sildenafil	Preferred Pharmaceuticals Inc.	ANDA	Current
71335-1437	Sildenafil Citrate	Sildenafil	Bryant Ranch Prepack	ANDA	Current
71335-1437	Sildenafil Citrate	Sildenafil	Bryant Ranch Prepack	ANDA	Current