Home NDC 50419-385 ALIQOPA
Product NDC 50419-385
11-digit product format 504190385
Labeler code 50419
Product ID 50419-385_dbc41472-e015-4763-b728-b98908319302
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name copanlisib
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Bayer HealthCare Pharmaceuticals Inc.
Application NDA209936
Marketing category NDA
Marketing start 2017-09-14
Marketing end 0000-00-00
Substance COPANLISIB
Active strength 15 mg/mL
Pharmacologic classes Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 27 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N209936-001 ALIQOPA COPANLISIB DIHYDROCHLORIDE 60MG/VIAL POWDER / INTRAVENOUS RLD 2017-09-14
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209936-001 RE46856 2029-10-22 U-2124 Drug substance, Drug product 2018-06-15 N209936-001 10383876 2032-03-29 Drug substance, Drug product 2019-09-18 N209936-001 9636344 2032-03-29 U-2124 2017-10-10
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 · 42 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 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD 2017-09-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD 2017-09-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD 2017-09-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD 2017-09-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD 2017-09-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD 2017-09-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD 2017-09-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD 2017-09-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD 2017-09-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD 2017-09-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD 2017-09-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD 2017-09-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD 2017-09-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD 2017-09-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD 2017-09-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-09-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-09-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-09-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-09-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-09-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-09-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-09-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-09-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-09-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-09-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-09-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-09-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-09-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD 2017-09-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD 2017-09-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-09-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-09-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-09-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-09-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-09-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-09-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-09-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-09-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-09-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209936-001 ALIQOPA 60MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-09-14 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 4 · 159 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N209936-001 RE46856 2029-10-22 U-2124 Drug substance, Drug product 2018-06-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209936-001 10383876 2032-03-29 Drug substance, Drug product 2019-09-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209936-001 9636344 2032-03-29 U-2124 2017-10-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209936-001 RE46856 2029-10-22 U-2124 Drug substance, Drug product 2018-06-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209936-001 10383876 2032-03-29 Drug substance, Drug product 2019-09-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209936-001 9636344 2032-03-29 U-2124 2017-10-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209936-001 RE46856 2029-10-22 U-2124 Drug substance, Drug product 2018-06-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209936-001 10383876 2032-03-29 Drug substance, Drug product 2019-09-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209936-001 9636344 2032-03-29 U-2124 2017-10-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209936-001 RE46856 2029-10-22 U-2124 Drug substance, Drug product 2018-06-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209936-001 10383876 2032-03-29 Drug substance, Drug product 2019-09-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209936-001 9636344 2032-03-29 U-2124 2017-10-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209936-001 RE46856 2029-10-22 U-2124 Drug substance, Drug product 2018-06-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209936-001 10383876 2032-03-29 Drug substance, Drug product 2019-09-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209936-001 9636344 2032-03-29 U-2124 2017-10-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209936-001 RE46856 2029-10-22 U-2124 Drug substance, Drug product 2018-06-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209936-001 10383876 2032-03-29 Drug substance, Drug product 2019-09-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209936-001 9636344 2032-03-29 U-2124 2017-10-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209936-001 7511041 2024-05-13 Drug substance, Drug product 2017-10-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209936-001 RE46856 2029-10-22 U-2124 Drug substance, Drug product 2018-06-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209936-001 10383876 2032-03-29 Drug substance, Drug product 2019-09-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209936-001 9636344 2032-03-29 U-2124 2017-10-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209936-001 7511041 2024-05-13 Drug substance, Drug product 2017-10-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209936-001 RE46856 2029-10-22 U-2124 Drug substance, Drug product 2018-06-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209936-001 10383876 2032-03-29 Drug substance, Drug product 2019-09-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209936-001 9636344 2032-03-29 U-2124 2017-10-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209936-001 7511041 2024-05-13 Drug substance, Drug product 2017-10-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209936-001 RE46856 2029-10-22 U-2124 Drug substance, Drug product 2018-06-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209936-001 10383876 2032-03-29 Drug substance, Drug product 2019-09-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209936-001 9636344 2032-03-29 U-2124 2017-10-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209936-001 7511041 2024-05-13 Drug substance, Drug product 2017-10-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209936-001 RE46856 2029-10-22 U-2124 Drug substance, Drug product 2018-06-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209936-001 10383876 2032-03-29 Drug substance, Drug product 2019-09-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209936-001 9636344 2032-03-29 U-2124 2017-10-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209936-001 7511041 2024-05-13 Drug substance, Drug product 2017-10-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209936-001 RE46856 2029-10-22 U-2124 Drug substance, Drug product 2018-06-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209936-001 10383876 2032-03-29 Drug substance, Drug product 2019-09-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209936-001 9636344 2032-03-29 U-2124 2017-10-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209936-001 7511041 2024-05-13 Drug substance, Drug product 2017-10-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209936-001 RE46856 2029-10-22 U-2124 Drug substance, Drug product 2018-06-15 79d66fd596c7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 53 observed states.
FDA-Initiated Inactive NDC Indexing# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50419-385-01 50419038501 1 VIAL, SINGLE-DOSE in 1 CARTON (50419-385-01) > 4 mL in 1 VIAL, SINGLE-DOSE 2017-09-14 0000-00-00 No No Current 50419-385-72 50419038572 1 VIAL, SINGLE-DOSE in 1 CARTON (50419-385-72) > 4 mL in 1 VIAL, SINGLE-DOSE 2018-10-30 0000-00-00 Yes No Current