Home Applications 205065 Application 205065
Type NDA
Sponsor BIOMARIN PHARM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 KUVAN SAPROPTERIN DIHYDROCHLORIDE POWDER;ORAL 100MG/PACKET Yes Yes 002 KUVAN SAPROPTERIN DIHYDROCHLORIDE POWDER;ORAL 500MG/PACKET Yes No
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 N205065-001 KUVAN SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET FOR SOLUTION / ORAL AB RLD, RS 2013-12-19 N205065-002 KUVAN SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET FOR SOLUTION / ORAL AB RLD, RS 2015-10-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 N205065-001 9216178 2032-11-01 Drug product 2016-01-15 N205065-001 9216178*PED 2033-05-01 Pediatric extension N205065-002 9216178 2032-11-01 Drug product 2016-01-15 N205065-002 9216178*PED 2033-05-01 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 3 · 82 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 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD, RS 2015-10-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL RLD 2015-10-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 observed states.
Observed Orange Book patent history# Patent history page 1 of 22 · 846 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 N205065-001 9216178 2032-11-01 Drug product 2016-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205065-001 9216178*PED 2033-05-01 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205065-002 9216178 2032-11-01 Drug product 2016-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205065-002 9216178*PED 2033-05-01 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-001 7566714 2024-11-17 U-1589 2014-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-001 7612073 2024-11-17 U-1010 2014-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-001 8067416 2024-11-17 U-1589 2014-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-001 9433624 2024-11-17 U-1589 2016-10-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-001 RE43797 2024-11-17 U-1590 2014-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-001 7566714*PED 2025-05-17 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-001 7612073*PED 2025-05-17 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-001 8067416*PED 2025-05-17 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-001 9433624*PED 2025-05-17 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-001 RE43797*PED 2025-05-17 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-001 9216178 2032-11-01 Drug product 2016-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-001 9216178*PED 2033-05-01 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-002 7566714 2024-11-17 U-1589 2015-11-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-002 7612073 2024-11-17 U-1010 2015-11-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-002 8067416 2024-11-17 U-1589 2015-11-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-002 9433624 2024-11-17 U-1589 2016-10-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-002 RE43797 2024-11-17 U-1590 2015-11-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-002 7566714*PED 2025-05-17 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-002 7612073*PED 2025-05-17 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-002 8067416*PED 2025-05-17 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-002 9433624*PED 2025-05-17 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-002 RE43797*PED 2025-05-17 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-002 9216178 2032-11-01 Drug product 2016-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-002 9216178*PED 2033-05-01 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205065-001 7566714*PED 2025-05-17 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205065-001 7612073*PED 2025-05-17 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205065-001 8067416*PED 2025-05-17 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205065-001 9433624*PED 2025-05-17 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205065-001 RE43797*PED 2025-05-17 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205065-001 9216178 2032-11-01 Drug product 2016-01-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205065-001 9216178*PED 2033-05-01 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205065-002 7566714*PED 2025-05-17 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205065-002 7612073*PED 2025-05-17 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205065-002 8067416*PED 2025-05-17 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205065-002 9433624*PED 2025-05-17 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205065-002 RE43797*PED 2025-05-17 Pediatric extension 6a471c1ec25d…
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 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68135-301 Kuvan SAPROPTERIN DIHYDROCHLORIDE BioMarin Pharmaceutical Inc. NDA Current 68135-301 Kuvan SAPROPTERIN DIHYDROCHLORIDE BioMarin Pharmaceutical Inc. NDA Current 68135-301 Kuvan SAPROPTERIN DIHYDROCHLORIDE BioMarin Pharmaceutical Inc. NDA Current 68135-301 Kuvan SAPROPTERIN DIHYDROCHLORIDE BioMarin Pharmaceutical Inc. NDA Current 68135-301 Kuvan SAPROPTERIN DIHYDROCHLORIDE BioMarin Pharmaceutical Inc. NDA Current 68135-301 Kuvan SAPROPTERIN DIHYDROCHLORIDE BioMarin Pharmaceutical Inc. NDA Current 68135-482 Kuvan sapropterin dihydrochloride BioMarin Pharmaceutical Inc. NDA Current 68135-482 Kuvan sapropterin dihydrochloride BioMarin Pharmaceutical Inc. NDA Current 68135-482 Kuvan sapropterin dihydrochloride BioMarin Pharmaceutical Inc. NDA Current 68135-482 Kuvan sapropterin dihydrochloride BioMarin Pharmaceutical Inc. NDA Current 68135-482 Kuvan sapropterin dihydrochloride BioMarin Pharmaceutical Inc. NDA Current 68135-482 Kuvan sapropterin dihydrochloride BioMarin Pharmaceutical Inc. NDA Current