Home Applications 216663 Application 216663
Type ANDA
Sponsor MANKIND PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 10MG No No 002 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 20MG No No 003 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 40MG No No 004 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 60MG No No 005 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 80MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216663-001 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2026-01-27 A216663-002 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2026-01-27 A216663-003 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 2026-01-27 A216663-004 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 2026-01-27 A216663-005 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2026-01-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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.
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 A216663-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2026-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216663-002 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2026-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216663-003 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 2026-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216663-004 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 2026-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216663-005 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2026-01-27 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216663-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 2026-01-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216663-002 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 2026-01-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216663-003 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 2026-01-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216663-004 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 2026-01-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216663-005 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2026-01-27 a50c72e98297…
Observed Orange Book normalized TE history# 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.