Home Applications 203340 Application 203340
Type NDA
Sponsor ARBOR PHARMS LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NYMALIZE NIMODIPINE SOLUTION;ORAL 60MG/20ML Yes Yes 002 NYMALIZE NIMODIPINE SOLUTION;ORAL 6MG/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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N203340-001 NYMALIZE NIMODIPINE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 N203340-002 NYMALIZE NIMODIPINE 6MG/ML SOLUTION / ORAL AB RLD, RS 2020-04-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N203340-002 AB
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N203340-002 10342787 2038-04-16 U-2804 Drug product 2020-05-08 N203340-002 10576070 2038-04-16 U-2804 Drug product 2020-05-08 N203340-002 11207306 2038-04-16 U-2804 2022-01-26 N203340-002 11413277 2038-04-16 U-2804 Drug product 2022-08-25 N203340-002 11806338 2038-04-16 Drug product 2023-11-17 N203340-002 12186308 2038-04-16 U-2804 Drug product 2025-01-27
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 · 78 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UTC 2026-02 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL AB RLD, RS 2020-04-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL AB RLD, RS 2020-04-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL AB RLD, RS 2020-04-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL AB RLD, RS 2020-04-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL AB RLD, RS 2020-04-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL RLD, RS 2020-04-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL RLD, RS 2020-04-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL RLD, RS 2020-04-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL RLD, RS 2020-04-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL RLD, RS 2020-04-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL RLD, RS 2020-04-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL RLD, RS 2020-04-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL RLD, RS 2020-04-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL RLD, RS 2020-04-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL RLD, RS 2020-04-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203340-001 NYMALIZE 3MG/ML SOLUTION / ORAL RLD 2013-05-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL RLD, RS 2020-04-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203340-001 NYMALIZE 3MG/ML SOLUTION / ORAL RLD 2013-05-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL RLD, RS 2020-04-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203340-001 NYMALIZE 60MG/20ML SOLUTION / ORAL RLD, RS 2013-05-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL RLD, RS 2020-04-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION / ORAL RLD 2013-05-10 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL RLD, RS 2020-04-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION / ORAL RLD 2013-05-10 87673890dc5c…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 6 · 216 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N203340-002 10342787 2038-04-16 U-2804 Drug product 2020-05-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203340-002 10576070 2038-04-16 U-2804 Drug product 2020-05-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203340-002 11207306 2038-04-16 U-2804 2022-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203340-002 11413277 2038-04-16 U-2804 Drug product 2022-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203340-002 11806338 2038-04-16 Drug product 2023-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203340-002 12186308 2038-04-16 U-2804 Drug product 2025-01-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203340-002 10342787 2038-04-16 U-2804 Drug product 2020-05-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203340-002 10576070 2038-04-16 U-2804 Drug product 2020-05-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203340-002 11207306 2038-04-16 U-2804 2022-01-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203340-002 11413277 2038-04-16 U-2804 Drug product 2022-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203340-002 11806338 2038-04-16 Drug product 2023-11-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203340-002 12186308 2038-04-16 U-2804 Drug product 2025-01-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203340-002 10342787 2038-04-16 U-2804 Drug product 2020-05-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203340-002 10576070 2038-04-16 U-2804 Drug product 2020-05-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203340-002 11207306 2038-04-16 U-2804 2022-01-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203340-002 11413277 2038-04-16 U-2804 Drug product 2022-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203340-002 11806338 2038-04-16 Drug product 2023-11-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203340-002 12186308 2038-04-16 U-2804 Drug product 2025-01-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203340-002 10342787 2038-04-16 U-2804 Drug product 2020-05-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203340-002 10576070 2038-04-16 U-2804 Drug product 2020-05-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203340-002 11207306 2038-04-16 U-2804 2022-01-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203340-002 11413277 2038-04-16 U-2804 Drug product 2022-08-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203340-002 11806338 2038-04-16 Drug product 2023-11-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203340-002 12186308 2038-04-16 U-2804 Drug product 2025-01-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203340-002 10342787 2038-04-16 U-2804 Drug product 2020-05-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203340-002 10576070 2038-04-16 U-2804 Drug product 2020-05-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203340-002 11207306 2038-04-16 U-2804 2022-01-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203340-002 11413277 2038-04-16 U-2804 Drug product 2022-08-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203340-002 11806338 2038-04-16 Drug product 2023-11-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203340-002 12186308 2038-04-16 U-2804 Drug product 2025-01-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203340-002 8517997 2024-05-14 Drug product 2020-07-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203340-002 10342787 2038-04-16 U-2804 Drug product 2020-05-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203340-002 10576070 2038-04-16 U-2804 Drug product 2020-05-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203340-002 11207306 2038-04-16 U-2804 2022-01-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203340-002 11413277 2038-04-16 U-2804 Drug product 2022-08-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203340-002 11806338 2038-04-16 Drug product 2023-11-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203340-002 8517997 2024-05-14 Drug product 2020-07-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203340-002 10342787 2038-04-16 U-2804 Drug product 2020-05-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203340-002 10576070 2038-04-16 U-2804 Drug product 2020-05-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203340-002 11207306 2038-04-16 U-2804 2022-01-26 2680178bc6a6…
Observed Orange Book exclusivity history# 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 · 16 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 24338-200 Nymalize nimodipine Arbor Pharmaceuticals NDA Current 24338-200 Nymalize nimodipine Arbor Pharmaceuticals NDA Current 24338-200 Nymalize nimodipine Arbor Pharmaceuticals NDA Current 24338-205 Nymalize nimodipine Arbor Pharmaceuticals NDA Current 24338-205 Nymalize nimodipine Arbor Pharmaceuticals NDA Current 24338-205 Nymalize nimodipine Arbor Pharmaceuticals NDA Current 24338-230 Nymalize nimodipine Arbor Pharmaceuticals NDA Current 24338-230 Nymalize nimodipine Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) NDA Current 24338-230 Nymalize nimodipine Arbor Pharmaceuticals NDA Current 24338-230 Nymalize nimodipine Arbor Pharmaceuticals NDA Current 24338-230 Nymalize nimodipine Arbor Pharmaceuticals NDA Current 24338-260 Nymalize nimodipine Arbor Pharmaceuticals NDA Current 24338-260 Nymalize nimodipine Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) NDA Current 24338-260 Nymalize nimodipine Arbor Pharmaceuticals NDA Current 24338-260 Nymalize nimodipine Arbor Pharmaceuticals NDA Current 24338-260 Nymalize nimodipine Arbor Pharmaceuticals NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 79888 SUPPL 2024-10-15 79883 SUPPL 2024-10-15 68778 SUPPL 2021-09-24 65707 SUPPL 2020-12-23 65701 SUPPL 2020-12-23 62857 SUPPL 2020-05-08 62535 SUPPL 2020-04-10 61548 SUPPL 2020-01-10 43428 ORIG 2014-03-06 24431 ORIG 2014-03-06 32411 ORIG 2013-05-14 19457 ORIG 2013-05-10