Home Applications 020899 Application 020899
Type NDA
Sponsor GE HEALTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OPTISON ALBUMIN HUMAN INJECTABLE;INJECTION 10MG/ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020899-001 OPTISON ALBUMIN HUMAN 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N020899-001 NPP 2028-05-09
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 2 · 41 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 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 cb3db0bc1861…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N020899-001 6723303 2021-04-20 Drug product 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N020899-001 6723303 2021-04-20 Drug product 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020899-001 6723303 2021-04-20 Drug product 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020899-001 6723303 2021-04-20 Drug product 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020899-001 6723303 2021-04-20 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020899-001 6723303 2021-04-20 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020899-001 6723303 2021-04-20 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020899-001 6723303 2021-04-20 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020899-001 6723303 2021-04-20 Drug product ea99ee380514…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020899-001 NPP 2028-05-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020899-001 NPP 2028-05-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020899-001 NPP 2028-05-09 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020899-001 NPP 2028-05-09 a50c72e98297…
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 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0407-2707 Optison Human Albumin Microspheres and Perflutren GE Healthcare Inc. NDA Current 0407-2707 Optison Human Albumin Microspheres and Perflutren GE Healthcare Inc. NDA Current 0407-2707 Optison Human Albumin Microspheres and Perflutren GE Healthcare Inc. NDA Current 0407-2707 Optison Human Albumin Microspheres and Perflutren GE Healthcare Inc. NDA Current 0407-2707 Optison Human Albumin Microspheres and Perflutren GE Healthcare Inc. NDA Current 0407-2707 Optison Human Albumin Microspheres and Perflutren GE Healthcare Inc. NDA Current 0407-2707 Optison Human Albumin Microspheres and Perflutren GE Healthcare Inc. NDA Current