Application 022206

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RAPAFLO	SILODOSIN	CAPSULE;ORAL	4MG	Yes	Yes
002	RAPAFLO	SILODOSIN	CAPSULE;ORAL	8MG	Yes	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
N022206-001	RAPAFLO	SILODOSIN	4MG	CAPSULE / ORAL		RLD	2008-10-08
N022206-002	RAPAFLO	SILODOSIN	8MG	CAPSULE / ORAL		RLD	2008-10-08

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022206-001	RAPAFLO	4MG	CAPSULE / ORAL		RLD	2008-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022206-002	RAPAFLO	8MG	CAPSULE / ORAL		RLD	2008-10-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022206-001	RAPAFLO	4MG	CAPSULE / ORAL		RLD	2008-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022206-002	RAPAFLO	8MG	CAPSULE / ORAL		RLD	2008-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022206-001	RAPAFLO	4MG	CAPSULE / ORAL		RLD	2008-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022206-002	RAPAFLO	8MG	CAPSULE / ORAL		RLD	2008-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022206-001	RAPAFLO	4MG	CAPSULE / ORAL		RLD	2008-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022206-002	RAPAFLO	8MG	CAPSULE / ORAL		RLD	2008-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022206-001	RAPAFLO	4MG	CAPSULE / ORAL	AB	RLD, RS	2008-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022206-002	RAPAFLO	8MG	CAPSULE / ORAL	AB	RLD	2008-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022206-001	RAPAFLO	4MG	CAPSULE / ORAL	AB	RLD, RS	2008-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022206-002	RAPAFLO	8MG	CAPSULE / ORAL	AB	RLD	2008-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022206-001	RAPAFLO	4MG	CAPSULE / ORAL	AB	RLD, RS	2008-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022206-002	RAPAFLO	8MG	CAPSULE / ORAL	AB	RLD	2008-10-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022206-001	RAPAFLO	4MG	CAPSULE / ORAL	AB	RLD, RS	2008-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022206-002	RAPAFLO	8MG	CAPSULE / ORAL	AB	RLD	2008-10-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022206-001	RAPAFLO	4MG	CAPSULE / ORAL	AB	RLD, RS	2008-10-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022206-002	RAPAFLO	8MG	CAPSULE / ORAL	AB	RLD	2008-10-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022206-001	RAPAFLO	4MG	CAPSULE / ORAL	AB	RLD, RS	2008-10-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022206-002	RAPAFLO	8MG	CAPSULE / ORAL	AB	RLD	2008-10-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022206-001	RAPAFLO	4MG	CAPSULE / ORAL	AB	RLD, RS	2008-10-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022206-002	RAPAFLO	8MG	CAPSULE / ORAL	AB	RLD	2008-10-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022206-001	RAPAFLO	4MG	CAPSULE / ORAL	AB	RLD, RS	2008-10-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022206-002	RAPAFLO	8MG	CAPSULE / ORAL	AB	RLD	2008-10-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022206-001	RAPAFLO	4MG	CAPSULE / ORAL	AB	RLD, RS	2008-10-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022206-002	RAPAFLO	8MG	CAPSULE / ORAL	AB	RLD	2008-10-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022206-001	RAPAFLO	4MG	CAPSULE / ORAL	AB	RLD, RS	2008-10-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022206-002	RAPAFLO	8MG	CAPSULE / ORAL	AB	RLD	2008-10-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022206-001	RAPAFLO	4MG	CAPSULE / ORAL	AB	RLD, RS	2008-10-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022206-002	RAPAFLO	8MG	CAPSULE / ORAL	AB	RLD	2008-10-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022206-001	RAPAFLO	4MG	CAPSULE / ORAL	AB	RLD, RS	2008-10-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022206-002	RAPAFLO	8MG	CAPSULE / ORAL	AB	RLD	2008-10-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022206-001	RAPAFLO	4MG	CAPSULE / ORAL	AB	RLD, RS	2008-10-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022206-002	RAPAFLO	8MG	CAPSULE / ORAL	AB	RLD	2008-10-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022206-001	RAPAFLO	4MG	CAPSULE / ORAL	AB	RLD, RS	2008-10-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022206-002	RAPAFLO	8MG	CAPSULE / ORAL	AB	RLD	2008-10-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022206-001	RAPAFLO	4MG	CAPSULE / ORAL	AB	RLD, RS	2008-10-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022206-002	RAPAFLO	8MG	CAPSULE / ORAL	AB	RLD	2008-10-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022206-001	RAPAFLO	4MG	CAPSULE / ORAL	AB	RLD, RS	2008-10-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022206-002	RAPAFLO	8MG	CAPSULE / ORAL	AB	RLD	2008-10-08	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022206-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022206-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022206-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022206-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022206-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022206-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022206-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022206-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022206-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022206-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022206-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022206-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022206-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022206-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022206-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022206-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022206-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022206-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022206-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022206-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022206-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022206-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022206-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022206-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022206-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022206-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022206-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022206-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022206-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022206-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022206-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022206-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022206-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022206-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022206-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022206-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022206-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022206-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022206-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022206-002	AB	1	`8869cabd3fbd…`

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

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
0023-6142	RAPAFLO	silodosin	Allergan, Inc.	NDA	Current
0023-6142	RAPAFLO	silodosin	Allergan, Inc.	NDA	Current
0023-6142	RAPAFLO	silodosin	Allergan, Inc.	NDA	Current
0023-6147	RAPAFLO	silodosin	Allergan, Inc.	NDA	Current
0023-6147	RAPAFLO	silodosin	Allergan, Inc.	NDA	Current
0023-6147	RAPAFLO	silodosin	Allergan, Inc.	NDA	Current
52544-151	RAPAFLO	silodosin	Actavis Pharma, Inc.	NDA	Current
52544-151	RAPAFLO	silodosin	Actavis Pharma, Inc.	NDA	Current
52544-151	RAPAFLO	silodosin	Actavis Pharma, Inc.	NDA	Current
52544-152	RAPAFLO	silodosin	Actavis Pharma, Inc.	NDA	Current
52544-152	RAPAFLO	silodosin	Actavis Pharma, Inc.	NDA	Current
52544-152	RAPAFLO	silodosin	Actavis Pharma, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65607	SUPPL	2020-12-17
65602	SUPPL	2020-12-16
38385	SUPPL	2013-07-17
7050	SUPPL	2013-07-15
7049	SUPPL	2012-12-19
17087	SUPPL	2012-12-18
29408	SUPPL	2010-03-08
17086	SUPPL	2010-03-05
17085	SUPPL	2009-02-20
29407	SUPPL	2009-02-18
44702	ORIG	2008-11-17
42451	ORIG	2008-11-14
38384	ORIG	2008-11-07
7048	ORIG	2008-10-14