Home Applications 204393 Application 204393
Type ANDA
Sponsor PIRAMAL CRITICAL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MITIGO MORPHINE SULFATE INJECTABLE;INJECTION 10MG/ML No No 002 MITIGO MORPHINE SULFATE INJECTABLE;INJECTION 25MG/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204393-001 MITIGO MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP 2018-07-16 A204393-002 MITIGO MORPHINE SULFATE 25MG/ML INJECTABLE / INJECTION AP 2018-07-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 · 84 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 2026-08-18 06:07:40 2026-07 A204393-001 MITIGO 10MG/ML INJECTABLE / INJECTION AP 2018-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204393-002 MITIGO 25MG/ML INJECTABLE / INJECTION AP 2018-07-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204393-001 MITIGO 10MG/ML INJECTABLE / INJECTION AP 2018-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204393-002 MITIGO 25MG/ML INJECTABLE / INJECTION AP 2018-07-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204393-001 MITIGO 10MG/ML INJECTABLE / INJECTION AP 2018-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204393-002 MITIGO 25MG/ML INJECTABLE / INJECTION AP 2018-07-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204393-001 MITIGO 10MG/ML INJECTABLE / INJECTION AP 2018-07-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204393-002 MITIGO 25MG/ML INJECTABLE / INJECTION AP 2018-07-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204393-001 MITIGO 10MG/ML INJECTABLE / INJECTION AP 2018-07-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204393-002 MITIGO 25MG/ML INJECTABLE / INJECTION AP 2018-07-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204393-001 MITIGO 10MG/ML INJECTABLE / INJECTION AP 2018-07-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204393-002 MITIGO 25MG/ML INJECTABLE / INJECTION AP 2018-07-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204393-001 MITIGO 10MG/ML INJECTABLE / INJECTION AP 2018-07-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204393-002 MITIGO 25MG/ML INJECTABLE / INJECTION AP 2018-07-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204393-001 MITIGO 10MG/ML INJECTABLE / INJECTION AP 2018-07-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204393-002 MITIGO 25MG/ML INJECTABLE / INJECTION AP 2018-07-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204393-001 MITIGO 10MG/ML INJECTABLE / INJECTION AP 2018-07-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204393-002 MITIGO 25MG/ML INJECTABLE / INJECTION AP 2018-07-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204393-001 MITIGO 10MG/ML INJECTABLE / INJECTION AP 2018-07-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204393-002 MITIGO 25MG/ML INJECTABLE / INJECTION AP 2018-07-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204393-001 MITIGO 10MG/ML INJECTABLE / INJECTION AP 2018-07-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204393-002 MITIGO 25MG/ML INJECTABLE / INJECTION AP 2018-07-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204393-001 MITIGO 10MG/ML INJECTABLE / INJECTION AP 2018-07-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204393-002 MITIGO 25MG/ML INJECTABLE / INJECTION AP 2018-07-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204393-001 MITIGO 10MG/ML INJECTABLE / INJECTION AP 2018-07-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204393-002 MITIGO 25MG/ML INJECTABLE / INJECTION AP 2018-07-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204393-001 MITIGO 10MG/ML INJECTABLE / INJECTION AP 2018-07-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204393-002 MITIGO 25MG/ML INJECTABLE / INJECTION AP 2018-07-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204393-001 MITIGO 10MG/ML INJECTABLE / INJECTION AP 2018-07-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204393-002 MITIGO 25MG/ML INJECTABLE / INJECTION AP 2018-07-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204393-001 MITIGO 10MG/ML INJECTABLE / INJECTION AP 2018-07-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204393-002 MITIGO 25MG/ML INJECTABLE / INJECTION AP 2018-07-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204393-001 MITIGO 10MG/ML INJECTABLE / INJECTION AP 2018-07-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204393-002 MITIGO 25MG/ML INJECTABLE / INJECTION AP 2018-07-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204393-001 MITIGO 10MG/ML INJECTABLE / INJECTION AP 2018-07-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204393-002 MITIGO 25MG/ML INJECTABLE / INJECTION AP 2018-07-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204393-001 MITIGO 10MG/ML INJECTABLE / INJECTION AP 2018-07-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A204393-002 MITIGO 25MG/ML INJECTABLE / INJECTION AP 2018-07-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204393-001 MITIGO 10MG/ML INJECTABLE / INJECTION AP 2018-07-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A204393-002 MITIGO 25MG/ML INJECTABLE / INJECTION AP 2018-07-16 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 · 18 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 66794-160 MITIGO Morphine Sulfate Piramal Critical Care, Inc. ANDA Current 66794-160 MITIGO Morphine Sulfate Piramal Critical Care, Inc. ANDA Current 66794-160 MITIGO Morphine Sulfate Piramal Critical Care, Inc. ANDA Current 66794-160 MITIGO Morphine Sulfate Piramal Critical Care, Inc. ANDA Current 66794-160 MITIGO Morphine Sulfate Piramal Critical Care, Inc. ANDA Current 66794-160 MITIGO Morphine Sulfate Piramal Critical Care, Inc. ANDA Current 66794-160 MITIGO Morphine Sulfate Piramal Critical Care, Inc. ANDA Current 66794-160 MITIGO Morphine Sulfate Piramal Critical Care, Inc. ANDA Current 66794-160 MITIGO Morphine Sulfate Piramal Critical Care, Inc. ANDA Current 66794-162 MITIGO Morphine Sulfate Piramal Critical Care, Inc. ANDA Current 66794-162 MITIGO Morphine Sulfate Piramal Critical Care, Inc. ANDA Current 66794-162 MITIGO Morphine Sulfate Piramal Critical Care, Inc. ANDA Current 66794-162 MITIGO Morphine Sulfate Piramal Critical Care, Inc. ANDA Current 66794-162 MITIGO Morphine Sulfate Piramal Critical Care, Inc. ANDA Current 66794-162 MITIGO Morphine Sulfate Piramal Critical Care, Inc. ANDA Current 66794-162 MITIGO Morphine Sulfate Piramal Critical Care, Inc. ANDA Current 66794-162 MITIGO Morphine Sulfate Piramal Critical Care, Inc. ANDA Current 66794-162 MITIGO Morphine Sulfate Piramal Critical Care, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 55231 ORIG 2018-08-20