Application 204726

Type: ANDA
Sponsor: SANDOZ INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SILODOSIN	SILODOSIN	CAPSULE;ORAL	4MG	No	No
002	SILODOSIN	SILODOSIN	CAPSULE;ORAL	8MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204726-001	SILODOSIN	SILODOSIN	4MG	CAPSULE / ORAL	AB		2017-03-31
A204726-002	SILODOSIN	SILODOSIN	8MG	CAPSULE / ORAL	AB		2017-03-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A204726-001	AB
A204726-002	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 3 · 84 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	A204726-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2017-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204726-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2017-03-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204726-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2017-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204726-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2017-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204726-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2017-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204726-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2017-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204726-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2017-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204726-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2017-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204726-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2017-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204726-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2017-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204726-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2017-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204726-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2017-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204726-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2017-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204726-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2017-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204726-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2017-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204726-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2017-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204726-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2017-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204726-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2017-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204726-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2017-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204726-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2017-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204726-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2017-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204726-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2017-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204726-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2017-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204726-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2017-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204726-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2017-03-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204726-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2017-03-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204726-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2017-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204726-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2017-03-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204726-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2017-03-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204726-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2017-03-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204726-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2017-03-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204726-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2017-03-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204726-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2017-03-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204726-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2017-03-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204726-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2017-03-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204726-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2017-03-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204726-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2017-03-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204726-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2017-03-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204726-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2017-03-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204726-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2017-03-31	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A204726-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204726-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204726-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204726-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204726-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204726-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204726-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204726-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204726-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204726-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204726-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204726-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204726-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204726-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204726-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204726-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204726-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204726-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204726-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204726-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204726-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204726-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204726-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204726-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204726-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204726-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204726-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204726-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204726-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204726-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204726-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204726-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204726-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204726-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204726-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204726-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204726-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204726-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204726-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204726-002	AB	1	`bb7c543d1eb4…`

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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Silodosin	SILODOSIN	Bryant Ranch Prepack	afbf4823-8663-4152-9346-ca42c7b7d722	2026-07-07	Warnings, Adverse reactions	Name fallback brand name: Silodosin generic name: SILODOSIN
SILODOSIN	SILODOSIN	Creekwood Pharmaceuticals LLC	43f83422-680f-411e-bbc3-2b092e64a017	2026-05-07	Warnings, Adverse reactions	Name fallback brand name: SILODOSIN generic name: SILODOSIN
Silodosin	SILODOSIN	Amneal Pharmaceuticals NY LLC	de619e27-9384-4b86-abdc-de0557cd39e8	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: Silodosin generic name: SILODOSIN
SILODOSIN	SILODOSIN	Bryant Ranch Prepack	aac3314b-af8c-400e-ba91-0cf2b95e70dd	2026-03-16	Warnings, Adverse reactions	Name fallback brand name: SILODOSIN generic name: SILODOSIN
SILODOSIN	SILODOSIN	Bryant Ranch Prepack	f2aa0cee-819d-45e8-95b3-86bc63b68368	2026-03-16	Warnings, Adverse reactions	Name fallback brand name: SILODOSIN generic name: SILODOSIN
Silodosin	SILODOSIN	AvKARE	ea3bbafb-d32a-d0d3-e053-2a95a90ac387	2026-01-15	Warnings, Adverse reactions	Name fallback brand name: Silodosin generic name: SILODOSIN
Silodosin	SILODOSIN	Ajanta Pharma USA Inc.	e863be56-d303-43bb-915a-1b2568674e31	2025-11-28	Warnings, Adverse reactions	Name fallback brand name: Silodosin generic name: SILODOSIN
SILODOSIN	SILODOSIN	PD-Rx Pharmaceuticals, Inc.	94bca72c-c74a-4181-8b6a-a0a2f654a0a7	2025-10-09	Warnings, Adverse reactions	Name fallback brand name: SILODOSIN generic name: SILODOSIN
Silodosin	SILODOSIN	Lupin Pharmaceuticals, Inc.	2300db48-477f-4357-8de9-f723737071b4	2025-10-07	Warnings, Adverse reactions	Name fallback brand name: Silodosin generic name: SILODOSIN
SILODOSIN	SILODOSIN	PD-Rx Pharmaceuticals, Inc.	365a86b3-748a-465d-b489-dba1479be670	2025-10-02	Warnings, Adverse reactions	Name fallback brand name: SILODOSIN generic name: SILODOSIN
Silodosin	SILODOSIN	Camber Pharmaceuticals, Inc.	b9880aad-5fbe-470b-a7a0-d963ba4bc98b	2024-06-05	Warnings, Adverse reactions	Name fallback brand name: Silodosin generic name: SILODOSIN
SILODOSIN	SILODOSIN	Aurobindo Pharma Limited	5e5038ea-9214-469b-8174-e5787be7a801	2024-05-08	Warnings, Adverse reactions	Name fallback brand name: SILODOSIN generic name: SILODOSIN
Silodosin	SILODOSIN	Alembic Pharmaceuticals Limited	322ce16e-485f-4fd2-bb30-6b4776bc9e85	2023-01-30	Warnings, Adverse reactions	Name fallback brand name: Silodosin generic name: SILODOSIN
Silodosin	SILODOSIN	Macleods Pharmaceuticals Limited	58af9a98-b1a1-4f30-b535-6647f1effed4	2022-06-28	Warnings, Adverse reactions	Name fallback brand name: Silodosin generic name: SILODOSIN
Silodosin	SILODOSIN	Amneal Pharmaceuticals NY LLC	455c98be-aa01-4393-915f-34d1859005c0	2022-04-28	Warnings, Adverse reactions	Name fallback brand name: Silodosin generic name: SILODOSIN
Silodosin	SILODOSIN	Alembic Pharmaceuticals Inc.	9a4d0d64-39bc-4d16-b040-8554eff19ee3	2021-07-15	Warnings, Adverse reactions	Name fallback brand name: Silodosin generic name: SILODOSIN
SILODOSIN	SILODOSIN	Novadoz Pharmaceuticals LLC	ee8d577e-948d-4164-9671-c876544ac83b	2021-07-08	Warnings, Adverse reactions	Name fallback brand name: SILODOSIN generic name: SILODOSIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-2623	Silodosin	Silodosin	Sandoz Inc	ANDA	Current
0781-2623	Silodosin	Silodosin	Sandoz Inc	ANDA	Current
0781-2623	Silodosin	Silodosin	Sandoz Inc	ANDA	Current
0781-2623	Silodosin	Silodosin	Sandoz Inc	ANDA	Current
0781-2623	Silodosin	Silodosin	Sandoz Inc	ANDA	Current
0781-2624	Silodosin	Silodosin	Sandoz Inc	ANDA	Current
0781-2624	Silodosin	Silodosin	Sandoz Inc	ANDA	Current
0781-2624	Silodosin	Silodosin	Sandoz Inc	ANDA	Current
0781-2624	Silodosin	Silodosin	Sandoz Inc	ANDA	Current
0781-2624	Silodosin	Silodosin	Sandoz Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
47867	ORIG	2017-04-05