Application 086651

Type: ANDA
Sponsor: INTL MEDICATION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ISOETHARINE HYDROCHLORIDE	ISOETHARINE HYDROCHLORIDE	SOLUTION;INHALATION	0.077%	No	No
002	ISOETHARINE HYDROCHLORIDE	ISOETHARINE HYDROCHLORIDE	SOLUTION;INHALATION	0.08%	No	No
003	ISOETHARINE HYDROCHLORIDE	ISOETHARINE HYDROCHLORIDE	SOLUTION;INHALATION	0.1%	No	No
004	ISOETHARINE HYDROCHLORIDE	ISOETHARINE HYDROCHLORIDE	SOLUTION;INHALATION	0.143%	No	No
005	ISOETHARINE HYDROCHLORIDE	ISOETHARINE HYDROCHLORIDE	SOLUTION;INHALATION	0.167%	No	No
006	ISOETHARINE HYDROCHLORIDE	ISOETHARINE HYDROCHLORIDE	SOLUTION;INHALATION	0.2%	No	No
007	ISOETHARINE HYDROCHLORIDE	ISOETHARINE HYDROCHLORIDE	SOLUTION;INHALATION	0.25%	No	No
008	ISOETHARINE HYDROCHLORIDE	ISOETHARINE HYDROCHLORIDE	SOLUTION;INHALATION	1%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
A086651-001	ISOETHARINE HYDROCHLORIDE	ISOETHARINE HYDROCHLORIDE	0.077%	SOLUTION / INHALATION	Approved before 1982
A086651-002	ISOETHARINE HYDROCHLORIDE	ISOETHARINE HYDROCHLORIDE	0.08%	SOLUTION / INHALATION	Approved before 1982
A086651-003	ISOETHARINE HYDROCHLORIDE	ISOETHARINE HYDROCHLORIDE	0.1%	SOLUTION / INHALATION	Approved before 1982
A086651-004	ISOETHARINE HYDROCHLORIDE	ISOETHARINE HYDROCHLORIDE	0.143%	SOLUTION / INHALATION	Approved before 1982
A086651-005	ISOETHARINE HYDROCHLORIDE	ISOETHARINE HYDROCHLORIDE	0.167%	SOLUTION / INHALATION	Approved before 1982
A086651-006	ISOETHARINE HYDROCHLORIDE	ISOETHARINE HYDROCHLORIDE	0.2%	SOLUTION / INHALATION	Approved before 1982
A086651-007	ISOETHARINE HYDROCHLORIDE	ISOETHARINE HYDROCHLORIDE	0.25%	SOLUTION / INHALATION	Approved before 1982
A086651-008	ISOETHARINE HYDROCHLORIDE	ISOETHARINE HYDROCHLORIDE	1%	SOLUTION / INHALATION	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 4 of 9 · 352 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086651-001	ISOETHARINE HYDROCHLORIDE	0.077%	SOLUTION / INHALATION	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086651-002	ISOETHARINE HYDROCHLORIDE	0.08%	SOLUTION / INHALATION	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086651-003	ISOETHARINE HYDROCHLORIDE	0.1%	SOLUTION / INHALATION	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086651-004	ISOETHARINE HYDROCHLORIDE	0.143%	SOLUTION / INHALATION	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086651-005	ISOETHARINE HYDROCHLORIDE	0.167%	SOLUTION / INHALATION	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086651-006	ISOETHARINE HYDROCHLORIDE	0.2%	SOLUTION / INHALATION	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086651-007	ISOETHARINE HYDROCHLORIDE	0.25%	SOLUTION / INHALATION	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086651-008	ISOETHARINE HYDROCHLORIDE	1%	SOLUTION / INHALATION	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086651-001	ISOETHARINE HYDROCHLORIDE	0.077%	SOLUTION / INHALATION	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A086651-002	ISOETHARINE HYDROCHLORIDE	0.08%	SOLUTION / INHALATION	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A086651-003	ISOETHARINE HYDROCHLORIDE	0.1%	SOLUTION / INHALATION	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A086651-004	ISOETHARINE HYDROCHLORIDE	0.143%	SOLUTION / INHALATION	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A086651-005	ISOETHARINE HYDROCHLORIDE	0.167%	SOLUTION / INHALATION	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A086651-006	ISOETHARINE HYDROCHLORIDE	0.2%	SOLUTION / INHALATION	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A086651-007	ISOETHARINE HYDROCHLORIDE	0.25%	SOLUTION / INHALATION	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A086651-008	ISOETHARINE HYDROCHLORIDE	1%	SOLUTION / INHALATION	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086651-001	ISOETHARINE HYDROCHLORIDE	0.077%	SOLUTION / INHALATION	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086651-002	ISOETHARINE HYDROCHLORIDE	0.08%	SOLUTION / INHALATION	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086651-003	ISOETHARINE HYDROCHLORIDE	0.1%	SOLUTION / INHALATION	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086651-004	ISOETHARINE HYDROCHLORIDE	0.143%	SOLUTION / INHALATION	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086651-005	ISOETHARINE HYDROCHLORIDE	0.167%	SOLUTION / INHALATION	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086651-006	ISOETHARINE HYDROCHLORIDE	0.2%	SOLUTION / INHALATION	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086651-007	ISOETHARINE HYDROCHLORIDE	0.25%	SOLUTION / INHALATION	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086651-008	ISOETHARINE HYDROCHLORIDE	1%	SOLUTION / INHALATION	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086651-001	ISOETHARINE HYDROCHLORIDE	0.077%	SOLUTION / INHALATION	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A086651-002	ISOETHARINE HYDROCHLORIDE	0.08%	SOLUTION / INHALATION	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A086651-003	ISOETHARINE HYDROCHLORIDE	0.1%	SOLUTION / INHALATION	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A086651-004	ISOETHARINE HYDROCHLORIDE	0.143%	SOLUTION / INHALATION	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A086651-005	ISOETHARINE HYDROCHLORIDE	0.167%	SOLUTION / INHALATION	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A086651-006	ISOETHARINE HYDROCHLORIDE	0.2%	SOLUTION / INHALATION	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A086651-007	ISOETHARINE HYDROCHLORIDE	0.25%	SOLUTION / INHALATION	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A086651-008	ISOETHARINE HYDROCHLORIDE	1%	SOLUTION / INHALATION	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086651-001	ISOETHARINE HYDROCHLORIDE	0.077%	SOLUTION / INHALATION	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A086651-002	ISOETHARINE HYDROCHLORIDE	0.08%	SOLUTION / INHALATION	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A086651-003	ISOETHARINE HYDROCHLORIDE	0.1%	SOLUTION / INHALATION	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A086651-004	ISOETHARINE HYDROCHLORIDE	0.143%	SOLUTION / INHALATION	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A086651-005	ISOETHARINE HYDROCHLORIDE	0.167%	SOLUTION / INHALATION	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A086651-006	ISOETHARINE HYDROCHLORIDE	0.2%	SOLUTION / INHALATION	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A086651-007	ISOETHARINE HYDROCHLORIDE	0.25%	SOLUTION / INHALATION	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A086651-008	ISOETHARINE HYDROCHLORIDE	1%	SOLUTION / INHALATION	Approved before 1982	`4b0b4de00fa7…`

Reported adverse events (FAERS/openFDA)#

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

Application 086651

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

Reported adverse events (FAERS/openFDA)#