Application 219767

Type: ANDA
Sponsor: RISING

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	CAPSULE;ORAL	0.4MG	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
A219767-001	TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2025-05-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A219767-001	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.

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	A219767-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2025-05-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219767-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2025-05-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219767-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2025-05-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219767-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2025-05-01	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219767-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2025-05-01	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A219767-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219767-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219767-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219767-001	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219767-001	AB	1	`a50c72e98297…`

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 2 of 4 · 63 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	AvPAK	62fa7fdf-c588-6f79-e053-2a91aa0a4c19	2025-10-22	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	f6b6aeab-bedd-4254-8811-4f65cf8a351f	2025-10-17	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Golden State Medical Supply, Inc.	18e9741b-969a-5a87-e063-6294a90a8851	2025-10-13	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	A-S Medication Solutions	6a2a4cc7-c88a-4555-a247-d1e63206ffc5	2025-10-02	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	A-S Medication Solutions	00bb2d71-1f21-494c-aa66-a82be3a0a8e6	2025-10-02	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	A-S Medication Solutions	1d70b04e-ca08-48d3-937b-eb701b40dd8a	2025-10-02	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Bryant Ranch Prepack	f185abfc-367d-45da-87c4-86d9f70bcd5d	2025-09-29	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	82d65964-de00-42c2-baaa-cc3de744b8eb	2025-09-25	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Major Pharmaceuticals	f8302a6e-b8da-4931-a279-b49e37943816	2025-09-23	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Ascend Laboratories, LLC	ed9988bc-0759-4c36-bee1-11b68dc1c84c	2025-08-04	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	American Health Packaging	8150a710-aee5-4841-ae1b-7d2e61281a8f	2025-07-01	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Bryant Ranch Prepack	3533e74e-5706-f594-e063-6394a90ab8a7	2025-06-13	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Bryant Ranch Prepack	36b8c36f-22e5-40f5-a99a-411115f13df4	2025-05-23	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin hydrochloride	TAMSULOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	35bbb655-19e2-00c2-e063-6394a90afbe3	2025-05-22	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	XLCare Pharmaceuticals, Inc	9108b999-4b99-469d-99a8-5ef0fa4ca00a	2025-03-28	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	c3ae55dd-6a0e-4f3a-82b6-2448e0545550	2025-03-20	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin hydrochloride	TAMSULOSIN HYDROCHLORIDE	EXELAN PHARMACEUTICALS, INC.	db6cb771-2cff-40b7-a5ef-ea3cf2a3b461	2025-03-01	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	cfd48327-a528-58cc-e053-2995a90a129f	2025-02-10	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	b85769ba-814e-1adb-e053-2a95a90a0556	2025-01-02	Warnings, Adverse reactions	Name fallback brand name: Tamsulosin Hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE
tamsulosin hydrochloride	TAMSULOSIN HYDROCHLORIDE	Sandoz Inc	fb120098-b007-4a33-80b8-b7279c7668ee	2024-09-30	Warnings, Adverse reactions	Name fallback brand name: tamsulosin hydrochloride generic name: TAMSULOSIN HYDROCHLORIDE