Home Applications 216097 Application 216097
Type ANDA
Sponsor AMNEAL PHARMS NY Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ISOTRETINOIN ISOTRETINOIN CAPSULE;ORAL 10MG No No 002 ISOTRETINOIN ISOTRETINOIN CAPSULE;ORAL 20MG No No 003 ISOTRETINOIN ISOTRETINOIN CAPSULE;ORAL 25MG No No 004 ISOTRETINOIN ISOTRETINOIN CAPSULE;ORAL 30MG No No 005 ISOTRETINOIN ISOTRETINOIN CAPSULE;ORAL 35MG No No 006 ISOTRETINOIN ISOTRETINOIN CAPSULE;ORAL 40MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216097-001 ISOTRETINOIN ISOTRETINOIN 10MG CAPSULE / ORAL 2025-10-07 A216097-002 ISOTRETINOIN ISOTRETINOIN 20MG CAPSULE / ORAL 2025-10-07 A216097-003 ISOTRETINOIN ISOTRETINOIN 25MG CAPSULE / ORAL 2025-10-07 A216097-004 ISOTRETINOIN ISOTRETINOIN 30MG CAPSULE / ORAL 2025-10-07 A216097-005 ISOTRETINOIN ISOTRETINOIN 35MG CAPSULE / ORAL 2025-10-07 A216097-006 ISOTRETINOIN ISOTRETINOIN 40MG CAPSULE / ORAL 2025-10-07
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 A216097-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2025-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216097-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2025-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216097-003 ISOTRETINOIN 25MG CAPSULE / ORAL AB2 2025-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216097-004 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2025-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216097-005 ISOTRETINOIN 35MG CAPSULE / ORAL AB2 2025-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216097-006 ISOTRETINOIN 40MG CAPSULE / ORAL AB2 2025-10-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216097-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2025-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216097-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2025-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216097-003 ISOTRETINOIN 25MG CAPSULE / ORAL AB2 2025-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216097-004 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2025-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216097-005 ISOTRETINOIN 35MG CAPSULE / ORAL AB2 2025-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216097-006 ISOTRETINOIN 40MG CAPSULE / ORAL AB2 2025-10-07 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216097-001 ISOTRETINOIN 10MG CAPSULE / ORAL 2025-10-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216097-002 ISOTRETINOIN 20MG CAPSULE / ORAL 2025-10-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216097-003 ISOTRETINOIN 25MG CAPSULE / ORAL 2025-10-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216097-004 ISOTRETINOIN 30MG CAPSULE / ORAL 2025-10-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216097-005 ISOTRETINOIN 35MG CAPSULE / ORAL 2025-10-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216097-006 ISOTRETINOIN 40MG CAPSULE / ORAL 2025-10-07 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Isotretinoin ISOTRETINOIN Amneal Pharmaceuticals NY LLC 9f1c8971-c6dc-4708-848b-5cee50b6c32a 2023-08-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216097 application number: ANDA216097