Home Applications 218194 Application 218194
Type ANDA
Sponsor AUROBINDO PHARMA 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 A218194-001 ISOTRETINOIN ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2024-01-29 A218194-002 ISOTRETINOIN ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2024-01-29 A218194-003 ISOTRETINOIN ISOTRETINOIN 25MG CAPSULE / ORAL AB2 2024-01-29 A218194-004 ISOTRETINOIN ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2024-01-29 A218194-005 ISOTRETINOIN ISOTRETINOIN 35MG CAPSULE / ORAL AB2 2024-01-29 A218194-006 ISOTRETINOIN ISOTRETINOIN 40MG CAPSULE / ORAL AB2 2024-01-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 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 3 · 102 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 A218194-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2024-01-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218194-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2024-01-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218194-003 ISOTRETINOIN 25MG CAPSULE / ORAL AB2 2024-01-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218194-004 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2024-01-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218194-005 ISOTRETINOIN 35MG CAPSULE / ORAL AB2 2024-01-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218194-006 ISOTRETINOIN 40MG CAPSULE / ORAL AB2 2024-01-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218194-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2024-01-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218194-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2024-01-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218194-003 ISOTRETINOIN 25MG CAPSULE / ORAL AB2 2024-01-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218194-004 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2024-01-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218194-005 ISOTRETINOIN 35MG CAPSULE / ORAL AB2 2024-01-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218194-006 ISOTRETINOIN 40MG CAPSULE / ORAL AB2 2024-01-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218194-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2024-01-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218194-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2024-01-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218194-003 ISOTRETINOIN 25MG CAPSULE / ORAL AB2 2024-01-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218194-004 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2024-01-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218194-005 ISOTRETINOIN 35MG CAPSULE / ORAL AB2 2024-01-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218194-006 ISOTRETINOIN 40MG CAPSULE / ORAL AB2 2024-01-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218194-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2024-01-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218194-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2024-01-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218194-003 ISOTRETINOIN 25MG CAPSULE / ORAL AB2 2024-01-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218194-004 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2024-01-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218194-005 ISOTRETINOIN 35MG CAPSULE / ORAL AB2 2024-01-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218194-006 ISOTRETINOIN 40MG CAPSULE / ORAL AB2 2024-01-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218194-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2024-01-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218194-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2024-01-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218194-003 ISOTRETINOIN 25MG CAPSULE / ORAL AB2 2024-01-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218194-004 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2024-01-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218194-005 ISOTRETINOIN 35MG CAPSULE / ORAL AB2 2024-01-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218194-006 ISOTRETINOIN 40MG CAPSULE / ORAL AB2 2024-01-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218194-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2024-01-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218194-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2024-01-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218194-003 ISOTRETINOIN 25MG CAPSULE / ORAL AB2 2024-01-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218194-004 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2024-01-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218194-005 ISOTRETINOIN 35MG CAPSULE / ORAL AB2 2024-01-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218194-006 ISOTRETINOIN 40MG CAPSULE / ORAL AB2 2024-01-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218194-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2024-01-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218194-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2024-01-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218194-003 ISOTRETINOIN 25MG CAPSULE / ORAL AB2 2024-01-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218194-004 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2024-01-29 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 102 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ISOTRETINOIN ISOTRETINOIN Aurobindo Pharma Limited 4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e6 2025-10-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 218194 application number: ANDA218194