Home Applications 076485 Application 076485
Type ANDA
Sponsor DOUGLAS PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MYORISAN ISOTRETINOIN CAPSULE;ORAL 10MG No No 002 MYORISAN ISOTRETINOIN CAPSULE;ORAL 20MG No No 003 MYORISAN ISOTRETINOIN CAPSULE;ORAL 40MG No No 004 MYORISAN ISOTRETINOIN CAPSULE;ORAL 30MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076485-001 MYORISAN ISOTRETINOIN 10MG CAPSULE / ORAL AB1 2012-01-19 A076485-002 MYORISAN ISOTRETINOIN 20MG CAPSULE / ORAL AB1 2012-01-19 A076485-003 MYORISAN ISOTRETINOIN 40MG CAPSULE / ORAL AB1 2012-01-19 A076485-004 MYORISAN ISOTRETINOIN 30MG CAPSULE / ORAL AB1 2015-08-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 5 · 164 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 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 16 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 61748-301 Myorisan isotretinoin VersaPharm, Inc. ANDA Current 61748-301 Myorisan isotretinoin Akorn Operating Company LLC ANDA Current 61748-301 Myorisan isotretinoin Versapharm Incorporated ANDA Current 61748-301 Myorisan isotretinoin Versapharm Incorporated ANDA Current 61748-302 Myorisan isotretinoin VersaPharm, Inc. ANDA Current 61748-302 Myorisan isotretinoin Akorn Operating Company LLC ANDA Current 61748-302 Myorisan isotretinoin Versapharm Incorporated ANDA Current 61748-302 Myorisan isotretinoin Versapharm Incorporated ANDA Current 61748-303 Myorisan isotretinoin VersaPharm, Inc. ANDA Current 61748-303 Myorisan isotretinoin Akorn Operating Company LLC ANDA Current 61748-303 Myorisan isotretinoin Versapharm Incorporated ANDA Current 61748-303 Myorisan isotretinoin Versapharm Incorporated ANDA Current 61748-304 Myorisan isotretinoin VersaPharm, Inc. ANDA Current 61748-304 Myorisan isotretinoin Akorn Operating Company LLC ANDA Current 61748-304 Myorisan isotretinoin Versapharm Incorporated ANDA Current 61748-304 Myorisan isotretinoin Versapharm Incorporated ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 24056 ORIG 2015-07-02 43081 ORIG 2013-05-10