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 2 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
2025-08-23 18:47 UTC	2025-08	A086651-001	ISOETHARINE HYDROCHLORIDE	0.077%	SOLUTION / INHALATION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086651-002	ISOETHARINE HYDROCHLORIDE	0.08%	SOLUTION / INHALATION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086651-003	ISOETHARINE HYDROCHLORIDE	0.1%	SOLUTION / INHALATION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086651-004	ISOETHARINE HYDROCHLORIDE	0.143%	SOLUTION / INHALATION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086651-005	ISOETHARINE HYDROCHLORIDE	0.167%	SOLUTION / INHALATION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086651-006	ISOETHARINE HYDROCHLORIDE	0.2%	SOLUTION / INHALATION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086651-007	ISOETHARINE HYDROCHLORIDE	0.25%	SOLUTION / INHALATION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086651-008	ISOETHARINE HYDROCHLORIDE	1%	SOLUTION / INHALATION	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086651-001	ISOETHARINE HYDROCHLORIDE	0.077%	SOLUTION / INHALATION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086651-002	ISOETHARINE HYDROCHLORIDE	0.08%	SOLUTION / INHALATION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086651-003	ISOETHARINE HYDROCHLORIDE	0.1%	SOLUTION / INHALATION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086651-004	ISOETHARINE HYDROCHLORIDE	0.143%	SOLUTION / INHALATION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086651-005	ISOETHARINE HYDROCHLORIDE	0.167%	SOLUTION / INHALATION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086651-006	ISOETHARINE HYDROCHLORIDE	0.2%	SOLUTION / INHALATION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086651-007	ISOETHARINE HYDROCHLORIDE	0.25%	SOLUTION / INHALATION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086651-008	ISOETHARINE HYDROCHLORIDE	1%	SOLUTION / INHALATION	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086651-001	ISOETHARINE HYDROCHLORIDE	0.077%	SOLUTION / INHALATION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086651-002	ISOETHARINE HYDROCHLORIDE	0.08%	SOLUTION / INHALATION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086651-003	ISOETHARINE HYDROCHLORIDE	0.1%	SOLUTION / INHALATION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086651-004	ISOETHARINE HYDROCHLORIDE	0.143%	SOLUTION / INHALATION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086651-005	ISOETHARINE HYDROCHLORIDE	0.167%	SOLUTION / INHALATION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086651-006	ISOETHARINE HYDROCHLORIDE	0.2%	SOLUTION / INHALATION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086651-007	ISOETHARINE HYDROCHLORIDE	0.25%	SOLUTION / INHALATION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086651-008	ISOETHARINE HYDROCHLORIDE	1%	SOLUTION / INHALATION	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086651-001	ISOETHARINE HYDROCHLORIDE	0.077%	SOLUTION / INHALATION	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086651-002	ISOETHARINE HYDROCHLORIDE	0.08%	SOLUTION / INHALATION	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086651-003	ISOETHARINE HYDROCHLORIDE	0.1%	SOLUTION / INHALATION	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086651-004	ISOETHARINE HYDROCHLORIDE	0.143%	SOLUTION / INHALATION	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086651-005	ISOETHARINE HYDROCHLORIDE	0.167%	SOLUTION / INHALATION	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086651-006	ISOETHARINE HYDROCHLORIDE	0.2%	SOLUTION / INHALATION	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086651-007	ISOETHARINE HYDROCHLORIDE	0.25%	SOLUTION / INHALATION	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086651-008	ISOETHARINE HYDROCHLORIDE	1%	SOLUTION / INHALATION	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086651-001	ISOETHARINE HYDROCHLORIDE	0.077%	SOLUTION / INHALATION	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086651-002	ISOETHARINE HYDROCHLORIDE	0.08%	SOLUTION / INHALATION	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086651-003	ISOETHARINE HYDROCHLORIDE	0.1%	SOLUTION / INHALATION	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086651-004	ISOETHARINE HYDROCHLORIDE	0.143%	SOLUTION / INHALATION	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086651-005	ISOETHARINE HYDROCHLORIDE	0.167%	SOLUTION / INHALATION	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086651-006	ISOETHARINE HYDROCHLORIDE	0.2%	SOLUTION / INHALATION	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086651-007	ISOETHARINE HYDROCHLORIDE	0.25%	SOLUTION / INHALATION	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086651-008	ISOETHARINE HYDROCHLORIDE	1%	SOLUTION / INHALATION	Approved before 1982	`2680178bc6a6…`

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)#