Application 218139

Type: NDA
Sponsor: NOVITIUM PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TEZRULY	TERAZOSIN HYDROCHLORIDE	SOLUTION;ORAL	EQ 1MG BASE/ML	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N218139-001	TEZRULY	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE/ML	SOLUTION / ORAL		RLD	2024-07-29

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N218139-001	11224572	2041-02-01	U-3990	Drug product	2024-09-24
N218139-001	11224572	2041-02-01	U-3991	Drug product	2024-09-24
N218139-001	12427108	2041-02-01	U-3990	Drug product	2025-10-03
N218139-001	12427108	2041-02-01	U-3991	Drug product	2025-10-03

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N218139-001	TEZRULY	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD	2024-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218139-001	TEZRULY	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD	2024-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218139-001	TEZRULY	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2024-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218139-001	TEZRULY	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2024-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218139-001	TEZRULY	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2024-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218139-001	TEZRULY	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2024-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218139-001	TEZRULY	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2024-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218139-001	TEZRULY	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD	2024-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218139-001	TEZRULY	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2024-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218139-001	TEZRULY	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD	2024-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218139-001	TEZRULY	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2024-07-29	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218139-001	TEZRULY	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD	2024-07-29	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N218139-001	11224572	2041-02-01	U-3990	Drug product	2024-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218139-001	11224572	2041-02-01	U-3991	Drug product	2024-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218139-001	12427108	2041-02-01	U-3990	Drug product	2025-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218139-001	12427108	2041-02-01	U-3991	Drug product	2025-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218139-001	11224572	2041-02-01	U-3990	Drug product	2024-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218139-001	11224572	2041-02-01	U-3991	Drug product	2024-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218139-001	12427108	2041-02-01	U-3990	Drug product	2025-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218139-001	12427108	2041-02-01	U-3991	Drug product	2025-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218139-001	11224572	2042-01-18	U-3990	Drug product	2024-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218139-001	11224572	2042-01-18	U-3991	Drug product	2024-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218139-001	11224572	2042-01-18	U-3990	Drug product	2024-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218139-001	11224572	2042-01-18	U-3991	Drug product	2024-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218139-001	11224572	2042-01-18	U-3990	Drug product	2024-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218139-001	11224572	2042-01-18	U-3991	Drug product	2024-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218139-001	11224572	2042-01-18	U-3990	Drug product	2024-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218139-001	11224572	2042-01-18	U-3991	Drug product	2024-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218139-001	11224572	2042-01-18	U-3990	Drug product	2024-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218139-001	11224572	2042-01-18	U-3991	Drug product	2024-09-24	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218139-001	11224572	2042-01-18	U-3990	Drug product	2024-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218139-001	11224572	2042-01-18	U-3991	Drug product	2024-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218139-001	11224572	2042-01-18	U-3990	Drug product	2024-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N218139-001	11224572	2042-01-18	U-3991	Drug product	2024-09-24	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218139-001	11224572	2041-02-01	U-3990	Drug product	2024-09-24	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218139-001	11224572	2041-02-01	U-3991	Drug product	2024-09-24	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218139-001	12427108	2041-02-01	U-3990	Drug product	2025-10-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218139-001	12427108	2041-02-01	U-3991	Drug product	2025-10-03	`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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TEZRULY	TERAZOSIN	ANI Pharmaceuticals, Inc.	69582e0c-6569-490c-8c14-999f3750336f	2025-04-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 218139 application number: NDA218139

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82445	ORIG	2025-06-03
79252	ORIG	2024-07-30
79251	ORIG	2024-07-30