Home Applications 022181 Application 022181
Type NDA
Sponsor BIOMARIN PHARM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 KUVAN SAPROPTERIN DIHYDROCHLORIDE TABLET;ORAL 100MG 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 N022181-001 KUVAN SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB RLD, RS 2007-12-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022181-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022181-001 7566462 2025-11-16 Drug product N022181-001 8003126 2025-11-16 2011-09-19 N022181-001 7566462*PED 2026-05-16 Pediatric extension N022181-001 8003126*PED 2026-05-16 Pediatric extension
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 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022181-001 KUVAN 100MG TABLET / ORAL RLD, RS 2007-12-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022181-001 KUVAN 100MG TABLET / ORAL RLD, RS 2007-12-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022181-001 KUVAN 100MG TABLET / ORAL RLD, RS 2007-12-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022181-001 KUVAN 100MG TABLET / ORAL RLD, RS 2007-12-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022181-001 KUVAN 100MG TABLET / ORAL AB RLD, RS 2007-12-13 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 18 · 688 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 N022181-001 7566462 2025-11-16 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022181-001 8003126 2025-11-16 2011-09-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022181-001 7566462*PED 2026-05-16 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022181-001 8003126*PED 2026-05-16 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022181-001 7566714 2024-11-17 U-989 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022181-001 7612073 2024-11-17 U-1010 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022181-001 7727987 2024-11-17 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022181-001 8067416 2024-11-17 U-989 2011-12-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022181-001 8318745 2024-11-17 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022181-001 9433624 2024-11-17 U-1589 2016-10-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022181-001 RE43797 2024-11-17 U-1156 2012-12-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022181-001 7566714*PED 2025-05-17 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022181-001 7612073*PED 2025-05-17 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022181-001 7727987*PED 2025-05-17 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022181-001 8067416*PED 2025-05-17 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022181-001 8318745*PED 2025-05-17 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022181-001 9433624*PED 2025-05-17 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022181-001 RE43797*PED 2025-05-17 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022181-001 7566462 2025-11-16 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022181-001 8003126 2025-11-16 2011-09-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022181-001 7566462*PED 2026-05-16 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022181-001 8003126*PED 2026-05-16 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022181-001 7566714*PED 2025-05-17 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022181-001 7612073*PED 2025-05-17 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022181-001 7727987*PED 2025-05-17 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022181-001 8067416*PED 2025-05-17 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022181-001 8318745*PED 2025-05-17 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022181-001 9433624*PED 2025-05-17 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022181-001 RE43797*PED 2025-05-17 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022181-001 7566462 2025-11-16 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022181-001 8003126 2025-11-16 2011-09-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022181-001 7566462*PED 2026-05-16 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022181-001 8003126*PED 2026-05-16 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022181-001 7566714*PED 2025-05-17 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022181-001 7612073*PED 2025-05-17 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022181-001 7727987*PED 2025-05-17 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022181-001 8067416*PED 2025-05-17 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022181-001 8318745*PED 2025-05-17 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022181-001 9433624*PED 2025-05-17 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022181-001 RE43797*PED 2025-05-17 Pediatric extension fd3edfee7708…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Kuvan SAPROPTERIN DIHYDROCHLORIDE BioMarin Pharmaceutical Inc. af38711e-8873-4790-a92d-4d583e23fb89 2024-08-26 Warnings, Adverse reactions Exact identifier application applno (NDA): 022181 application number: NDA022181 ndc (product): 68135-300
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 43598-749 Sapropterin Dihydrochloride Sapropterin Dihydrochloride Dr. Reddys Laboratories Inc. NDA Current 43598-749 Sapropterin Dihydrochloride Sapropterin Dihydrochloride Dr. Reddys Laboratories Inc. NDA Current 68135-300 Kuvan SAPROPTERIN DIHYDROCHLORIDE BioMarin Pharmaceutical Inc. NDA Current 68135-300 Kuvan SAPROPTERIN DIHYDROCHLORIDE BioMarin Pharmaceutical Inc. NDA Current 68135-300 Kuvan SAPROPTERIN DIHYDROCHLORIDE BioMarin Pharmaceutical Inc. NDA Current 68135-300 Kuvan SAPROPTERIN DIHYDROCHLORIDE BioMarin Pharmaceutical Inc. NDA Current 68135-300 Kuvan SAPROPTERIN DIHYDROCHLORIDE BioMarin Pharmaceutical Inc. NDA Current 68135-300 Kuvan SAPROPTERIN DIHYDROCHLORIDE BioMarin Pharmaceutical Inc. NDA Current