Application 210394

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 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
A210394-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB		2018-05-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210394-001	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	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`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	A210394-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210394-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210394-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210394-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210394-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210394-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210394-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210394-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210394-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210394-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210394-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210394-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210394-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210394-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210394-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210394-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210394-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210394-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210394-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210394-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210394-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210394-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210394-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210394-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210394-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210394-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210394-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210394-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210394-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210394-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210394-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210394-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210394-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210394-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210394-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210394-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210394-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210394-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210394-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210394-001	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	REMEDYREPACK INC.	e4f41e9e-d508-4f91-8677-8a19b07139de	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210394 application number: ANDA210394 ndc (product): 70518-3433
Sildenafil	SILDENAFIL	NuCare Pharmaceuticals,Inc.	cc3656ac-3a38-a650-e053-2a95a90a912a	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210394 application number: ANDA210394 ndc (product): 68071-2537
Sildenafil	SILDENAFIL	Quallent Pharmaceuticals Health LLC	333ca682-931f-4edb-95d6-2edbd87631cf	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210394 application number: ANDA210394
Sildenafil	SILDENAFIL	Ajanta Pharma USA Inc.	31c0f8ab-ed2e-4ead-a8c0-4055f6c43783	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210394 application number: ANDA210394 ndc (product): 27241-124
Sildenafil	SILDENAFIL	Proficient Rx LP	7dd302cd-b84d-4d7d-bd1e-2916febbaea5	2025-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210394 application number: ANDA210394
Sildenafil	SILDENAFIL	NuCare Pharmaceuticals,Inc.	d35f8d6b-e642-78bb-e053-2995a90abb2e	2025-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210394 application number: ANDA210394 ndc (product): 68071-2602
SILDENAFIL	SILDENAFIL	DirectRx	d1ee9139-13ac-7d5b-e053-2995a90a8e50	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210394 application number: ANDA210394 ndc (product): 72189-298
Sildenafil	SILDENAFIL	Preferred Pharmaceuticals Inc.	d887377e-90c5-44dc-8455-b23a6755b36f	2025-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210394 application number: ANDA210394 ndc (product): 68788-7974
Sildenafil	SILDENAFIL	Bryant Ranch Prepack	fe848310-57d8-4492-829c-3e2535754a55	2024-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210394 application number: ANDA210394 ndc (product): 71335-1963

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
27241-124	Sildenafil	Sildenafil	Ajanta Pharma USA Inc.	ANDA	Current
27241-124	Sildenafil	Sildenafil	Ajanta Pharma Limited	ANDA	Current
68071-2537	Sildenafil	Sildenafil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2602	Sildenafil	Sildenafil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2608	Sildenafil	Sildenafil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7974	Sildenafil	Sildenafil	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7974	Sildenafil	Sildenafil	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-3433	Sildenafil	Sildenafil	REMEDYREPACK INC.	ANDA	Current
70518-3433	Sildenafil	Sildenafil	REMEDYREPACK INC.	ANDA	Current
71335-1963	Sildenafil	Sildenafil	Bryant Ranch Prepack	ANDA	Current
71335-1963	Sildenafil	Sildenafil	Bryant Ranch Prepack	ANDA	Current
72189-298	SILDENAFIL	SILDENAFIL	DirectRx	ANDA	Current
72189-298	SILDENAFIL	SILDENAFIL	DirectRx	ANDA	Current
72189-298	SILDENAFIL	SILDENAFIL	DirectRx	ANDA	Current