Home Applications 077616 Application 077616
Type ANDA
Sponsor MYLAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 80MG No No 002 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 120MG No No 003 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 160MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 TE codes RLD / RS Approval date A077616-001 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 A077616-002 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2007-02-07 A077616-003 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2007-02-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 123 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 2026-02-19 14:30 UTC 2026-02 A077616-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077616-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2007-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077616-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2007-02-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077616-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077616-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2007-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077616-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2007-02-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077616-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077616-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2007-02-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077616-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2007-02-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077616-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077616-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2007-02-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077616-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2007-02-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077616-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077616-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2007-02-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077616-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2007-02-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077616-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077616-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2007-02-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077616-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2007-02-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077616-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077616-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2007-02-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077616-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2007-02-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077616-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077616-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2007-02-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077616-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2007-02-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077616-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077616-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2007-02-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077616-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2007-02-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077616-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077616-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2007-02-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077616-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2007-02-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077616-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077616-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2007-02-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077616-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2007-02-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077616-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077616-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2007-02-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077616-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2007-02-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077616-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077616-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2007-02-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077616-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2007-02-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077616-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 81 observed states.
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0378-5123 Sotalol Hydrochloride sotalol hydrochloride Mylan Pharmaceuticals Inc. ANDA Current 0378-5124 Sotalol Hydrochloride sotalol hydrochloride Mylan Pharmaceuticals Inc. ANDA Current 0378-5125 Sotalol Hydrochloride sotalol hydrochloride Mylan Pharmaceuticals Inc. ANDA Current