Application 086576

Type: ANDA
Sponsor: FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TYZINE	TETRAHYDROZOLINE HYDROCHLORIDE	SOLUTION;NASAL	0.1%	No	No
002	TYZINE	TETRAHYDROZOLINE HYDROCHLORIDE	SOLUTION;NASAL	0.05%	No	Yes
003	TYZINE	TETRAHYDROZOLINE HYDROCHLORIDE	SPRAY;NASAL	0.1%	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
A086576-001	TYZINE	TETRAHYDROZOLINE HYDROCHLORIDE	0.1%	SOLUTION / NASAL	Approved before 1982
A086576-002	TYZINE	TETRAHYDROZOLINE HYDROCHLORIDE	0.05%	SOLUTION / NASAL	RS, Approved before 1982
A086576-003	TYZINE	TETRAHYDROZOLINE HYDROCHLORIDE	0.1%	SPRAY / NASAL	RS, Approved before 1982

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 2 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086576-002	TYZINE	0.05%	SOLUTION / NASAL	RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086576-003	TYZINE	0.1%	SPRAY / NASAL	RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086576-001	TYZINE	0.1%	SOLUTION / NASAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086576-002	TYZINE	0.05%	SOLUTION / NASAL	RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086576-003	TYZINE	0.1%	SPRAY / NASAL	RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086576-001	TYZINE	0.1%	SOLUTION / NASAL	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A086576-002	TYZINE	0.05%	SOLUTION / NASAL	RS, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A086576-003	TYZINE	0.1%	SPRAY / NASAL	RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086576-001	TYZINE	0.1%	SOLUTION / NASAL	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086576-002	TYZINE	0.05%	SOLUTION / NASAL	RS, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086576-003	TYZINE	0.1%	SPRAY / NASAL	RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086576-001	TYZINE	0.1%	SOLUTION / NASAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A086576-002	TYZINE	0.05%	SOLUTION / NASAL	RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A086576-003	TYZINE	0.1%	SPRAY / NASAL	RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086576-001	TYZINE	0.1%	SOLUTION / NASAL	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A086576-002	TYZINE	0.05%	SOLUTION / NASAL	RS, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A086576-003	TYZINE	0.1%	SPRAY / NASAL	RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086576-001	TYZINE	0.1%	SOLUTION / NASAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A086576-002	TYZINE	0.05%	SOLUTION / NASAL	RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A086576-003	TYZINE	0.1%	SPRAY / NASAL	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086576-001	TYZINE	0.1%	SOLUTION / NASAL	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A086576-002	TYZINE	0.05%	SOLUTION / NASAL	RS, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A086576-003	TYZINE	0.1%	SPRAY / NASAL	RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086576-001	TYZINE	0.1%	SOLUTION / NASAL	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A086576-002	TYZINE	0.05%	SOLUTION / NASAL	RS, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A086576-003	TYZINE	0.1%	SPRAY / NASAL	RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086576-001	TYZINE	0.1%	SOLUTION / NASAL	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086576-002	TYZINE	0.05%	SOLUTION / NASAL	RS, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086576-003	TYZINE	0.1%	SPRAY / NASAL	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086576-001	TYZINE	0.1%	SOLUTION / NASAL	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A086576-002	TYZINE	0.05%	SOLUTION / NASAL	RS, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A086576-003	TYZINE	0.1%	SPRAY / NASAL	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086576-001	TYZINE	0.1%	SOLUTION / NASAL	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A086576-002	TYZINE	0.05%	SOLUTION / NASAL	RS, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A086576-003	TYZINE	0.1%	SPRAY / NASAL	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086576-001	TYZINE	0.1%	SOLUTION / NASAL	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A086576-002	TYZINE	0.05%	SOLUTION / NASAL	RS, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A086576-003	TYZINE	0.1%	SPRAY / NASAL	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086576-001	TYZINE	0.1%	SOLUTION / NASAL	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A086576-002	TYZINE	0.05%	SOLUTION / NASAL	RS, Approved before 1982	`3f01610625f2…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medics Choice Eye Drops Original Redness Reliever	TETRAHYDROZOLINE HYDROCHLORIDE	KC Pharmaceuticals, Inc.	e42cb1bf-b985-4a1b-9a9b-ac27c2a5d7be	2025-12-30	Warnings	Name fallback generic name: TETRAHYDROZOLINE HYDROCHLORIDE
Lil Drug Store Eye Drops Redness Reliever	TETRAHYDROZOLINE HYDROCHLORIDE	Lil Drug Store Products, Inc	d2a47e98-a04c-47ec-aded-d1c894f040e2	2024-12-30	Warnings	Name fallback generic name: TETRAHYDROZOLINE HYDROCHLORIDE
Visine Red Eye Comfort	TETRAHYDROZOLINE HYDROCHLORIDE	Kenvue Brands LLC	d7abd7cb-e094-481f-bea5-a5983e2c9ef4	2024-11-13	Warnings	Name fallback generic name: TETRAHYDROZOLINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.