Application 091479

Type: ANDA
Sponsor: TORRENT PHARMS 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
A091479-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB		2012-11-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091479-001	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	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`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	A091479-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091479-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091479-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091479-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091479-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091479-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091479-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091479-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091479-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091479-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091479-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091479-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091479-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091479-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091479-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091479-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091479-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091479-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091479-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091479-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091479-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091479-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091479-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091479-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091479-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091479-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091479-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091479-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091479-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091479-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091479-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091479-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091479-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091479-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091479-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091479-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091479-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091479-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091479-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091479-001	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	Bryant Ranch Prepack	486dcfc4-f07a-4a78-86f0-f1c5ae448dc1	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091479 application number: ANDA091479
SILDENAFIL	SILDENAFIL	Major Pharmaceuticals	a65b5fb3-ca3c-4226-9caa-42fb9a2f7373	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091479 application number: ANDA091479 ndc (product): 0904-6671
Sildenafil	SILDENAFIL	Torrent Pharmaceuticals Limited	1bc081f2-399d-43fa-9e0f-9f8df0118e99	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091479 application number: ANDA091479 ndc (product): 13668-185
Sildenafil	SILDENAFIL	NuCare Pharmaceuticals, Inc.	48c56418-0e45-083f-e063-6294a90a57b3	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091479 application number: ANDA091479
SILDENAFIL	SILDENAFIL	Cardinal Health 107, LLC	c5ac2265-393a-4fbe-b974-1dd0b9243ec8	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091479 application number: ANDA091479
Sildenafil	SILDENAFIL	Proficient Rx LP	71140bd5-0a51-4c01-ad0d-193d08ea67dd	2025-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091479 application number: ANDA091479
SILDENAFIL CITRATE	SILDENAFIL CITRATE	A-S Medication Solutions	28a3376b-e50e-4789-9916-803ba29a1522	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091479 application number: ANDA091479 ndc (product): 50090-3905
Sildenafil Citrate	SILDENAFIL CITRATE	Advanced Rx Pharmacy of Tennessee, LLC	f925abbe-4977-00b0-e053-6294a90a6e53	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091479 application number: ANDA091479
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Asclemed USA, Inc.	49a95b25-08b3-4cfe-a60b-c5132c280be2	2023-09-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091479 application number: ANDA091479

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6671	SILDENAFIL CITRATE	SILDENAFIL CITRATE	Major Pharmaceuticals	ANDA	Current
0904-6671	SILDENAFIL CITRATE	SILDENAFIL CITRATE	Major Pharmaceuticals	ANDA	Current
13668-185	SILDENAFIL CITRATE	SILDENAFIL CITRATE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-185	SILDENAFIL CITRATE	SILDENAFIL CITRATE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-185	SILDENAFIL CITRATE	SILDENAFIL CITRATE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-185	SILDENAFIL CITRATE	SILDENAFIL CITRATE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-185	SILDENAFIL CITRATE	SILDENAFIL CITRATE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-185	SILDENAFIL CITRATE	SILDENAFIL CITRATE	Torrent Pharmaceuticals Limited	ANDA	Current
50090-3905	SILDENAFIL CITRATE	SILDENAFIL CITRATE	A-S Medication Solutions	ANDA	Current
50090-3905	SILDENAFIL CITRATE	SILDENAFIL CITRATE	A-S Medication Solutions	ANDA	Current
50436-0185	SILDENAFIL CITRATE	SILDENAFIL CITRATE	Unit Dose Services	ANDA	Current
51655-131	SILDENAFIL	SILDENAFIL	Northwind Pharmaceuticals, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31534	ORIG	2012-11-07