Home Applications 086651 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 43 .
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 TE codes RLD / RS Approval date 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 1 of 9 · 344 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A086651-001 ISOETHARINE HYDROCHLORIDE 0.077% SOLUTION / INHALATION Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 A086651-002 ISOETHARINE HYDROCHLORIDE 0.08% SOLUTION / INHALATION Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 A086651-003 ISOETHARINE HYDROCHLORIDE 0.1% SOLUTION / INHALATION Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 A086651-004 ISOETHARINE HYDROCHLORIDE 0.143% SOLUTION / INHALATION Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 A086651-005 ISOETHARINE HYDROCHLORIDE 0.167% SOLUTION / INHALATION Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 A086651-006 ISOETHARINE HYDROCHLORIDE 0.2% SOLUTION / INHALATION Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 A086651-007 ISOETHARINE HYDROCHLORIDE 0.25% SOLUTION / INHALATION Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 A086651-008 ISOETHARINE HYDROCHLORIDE 1% SOLUTION / INHALATION Approved before 1982 84e616aacf4f…2026-08-18 06:07:40 2026-07 A086651-001 ISOETHARINE HYDROCHLORIDE 0.077% SOLUTION / INHALATION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A086651-002 ISOETHARINE HYDROCHLORIDE 0.08% SOLUTION / INHALATION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A086651-003 ISOETHARINE HYDROCHLORIDE 0.1% SOLUTION / INHALATION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A086651-004 ISOETHARINE HYDROCHLORIDE 0.143% SOLUTION / INHALATION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A086651-005 ISOETHARINE HYDROCHLORIDE 0.167% SOLUTION / INHALATION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A086651-006 ISOETHARINE HYDROCHLORIDE 0.2% SOLUTION / INHALATION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A086651-007 ISOETHARINE HYDROCHLORIDE 0.25% SOLUTION / INHALATION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A086651-008 ISOETHARINE HYDROCHLORIDE 1% SOLUTION / INHALATION Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A086651-001 ISOETHARINE HYDROCHLORIDE 0.077% SOLUTION / INHALATION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A086651-002 ISOETHARINE HYDROCHLORIDE 0.08% SOLUTION / INHALATION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A086651-003 ISOETHARINE HYDROCHLORIDE 0.1% SOLUTION / INHALATION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A086651-004 ISOETHARINE HYDROCHLORIDE 0.143% SOLUTION / INHALATION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A086651-005 ISOETHARINE HYDROCHLORIDE 0.167% SOLUTION / INHALATION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A086651-006 ISOETHARINE HYDROCHLORIDE 0.2% SOLUTION / INHALATION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A086651-007 ISOETHARINE HYDROCHLORIDE 0.25% SOLUTION / INHALATION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A086651-008 ISOETHARINE HYDROCHLORIDE 1% SOLUTION / INHALATION Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A086651-001 ISOETHARINE HYDROCHLORIDE 0.077% SOLUTION / INHALATION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A086651-002 ISOETHARINE HYDROCHLORIDE 0.08% SOLUTION / INHALATION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A086651-003 ISOETHARINE HYDROCHLORIDE 0.1% SOLUTION / INHALATION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A086651-004 ISOETHARINE HYDROCHLORIDE 0.143% SOLUTION / INHALATION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A086651-005 ISOETHARINE HYDROCHLORIDE 0.167% SOLUTION / INHALATION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A086651-006 ISOETHARINE HYDROCHLORIDE 0.2% SOLUTION / INHALATION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A086651-007 ISOETHARINE HYDROCHLORIDE 0.25% SOLUTION / INHALATION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A086651-008 ISOETHARINE HYDROCHLORIDE 1% SOLUTION / INHALATION Approved before 1982 31067a03dcf5…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…