Home Applications 205739 Application 205739
Type NDA
Sponsor RELYPSA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VELTASSA PATIROMER SORBITEX CALCIUM POWDER;ORAL EQ 8.4GM BASE/PACKET Yes No 002 VELTASSA PATIROMER SORBITEX CALCIUM POWDER;ORAL EQ 16.8GM BASE/PACKET Yes No 003 VELTASSA PATIROMER SORBITEX CALCIUM POWDER;ORAL EQ 25.2GM BASE/PACKET Yes Yes 004 VELTASSA PATIROMER SORBITEX CALCIUM POWDER;ORAL EQ 1GM BASE/PACKET Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N205739-001 VELTASSA PATIROMER SORBITEX CALCIUM EQ 8.4GM BASE/PACKET POWDER / ORAL RLD 2015-10-21 N205739-002 VELTASSA PATIROMER SORBITEX CALCIUM EQ 16.8GM BASE/PACKET POWDER / ORAL RLD, RS 2015-10-21 N205739-003 VELTASSA PATIROMER SORBITEX CALCIUM EQ 25.2GM BASE/PACKET POWDER / ORAL RLD 2015-10-21 N205739-004 VELTASSA PATIROMER SORBITEX CALCIUM EQ 1GM BASE/PACKET POWDER / ORAL RLD 2023-10-02
Orange Book patents# Current patent rows page 1 of 1 · 28 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 matching rows.
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 4 · 150 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 2026-09-14 22:38:34 2026-08 N205739-001 VELTASSA EQ 8.4GM BASE/PACKET POWDER / ORAL RLD 2015-10-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-002 VELTASSA EQ 16.8GM BASE/PACKET POWDER / ORAL RLD, RS 2015-10-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-003 VELTASSA EQ 25.2GM BASE/PACKET POWDER / ORAL RLD 2015-10-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-004 VELTASSA EQ 1GM BASE/PACKET POWDER / ORAL RLD 2023-10-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 N205739-001 VELTASSA EQ 8.4GM BASE/PACKET POWDER / ORAL RLD 2015-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205739-002 VELTASSA EQ 16.8GM BASE/PACKET POWDER / ORAL RLD, RS 2015-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205739-003 VELTASSA EQ 25.2GM BASE/PACKET POWDER / ORAL RLD 2015-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205739-004 VELTASSA EQ 1GM BASE/PACKET POWDER / ORAL RLD 2023-10-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205739-001 VELTASSA EQ 8.4GM BASE/PACKET POWDER / ORAL RLD 2015-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205739-002 VELTASSA EQ 16.8GM BASE/PACKET POWDER / ORAL RLD, RS 2015-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205739-003 VELTASSA EQ 25.2GM BASE/PACKET POWDER / ORAL RLD 2015-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205739-004 VELTASSA EQ 1GM BASE/PACKET POWDER / ORAL RLD 2023-10-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205739-001 VELTASSA EQ 8.4GM BASE/PACKET POWDER / ORAL RLD 2015-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205739-002 VELTASSA EQ 16.8GM BASE/PACKET POWDER / ORAL RLD, RS 2015-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205739-003 VELTASSA EQ 25.2GM BASE/PACKET POWDER / ORAL RLD 2015-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205739-004 VELTASSA EQ 1GM BASE/PACKET POWDER / ORAL RLD 2023-10-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205739-001 VELTASSA EQ 8.4GM BASE/PACKET POWDER / ORAL RLD 2015-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205739-002 VELTASSA EQ 16.8GM BASE/PACKET POWDER / ORAL RLD, RS 2015-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205739-003 VELTASSA EQ 25.2GM BASE/PACKET POWDER / ORAL RLD 2015-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205739-004 VELTASSA EQ 1GM BASE/PACKET POWDER / ORAL RLD 2023-10-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205739-001 VELTASSA EQ 8.4GM BASE/PACKET POWDER / ORAL RLD 2015-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205739-002 VELTASSA EQ 16.8GM BASE/PACKET POWDER / ORAL RLD, RS 2015-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205739-003 VELTASSA EQ 25.2GM BASE/PACKET POWDER / ORAL RLD 2015-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205739-004 VELTASSA EQ 1GM BASE/PACKET POWDER / ORAL RLD 2023-10-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205739-001 VELTASSA EQ 8.4GM BASE/PACKET POWDER / ORAL RLD 2015-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205739-002 VELTASSA EQ 16.8GM BASE/PACKET POWDER / ORAL RLD, RS 2015-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205739-003 VELTASSA EQ 25.2GM BASE/PACKET POWDER / ORAL RLD 2015-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205739-004 VELTASSA EQ 1GM BASE/PACKET POWDER / ORAL RLD 2023-10-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205739-001 VELTASSA EQ 8.4GM BASE/PACKET POWDER / ORAL RLD 2015-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205739-002 VELTASSA EQ 16.8GM BASE/PACKET POWDER / ORAL RLD, RS 2015-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205739-003 VELTASSA EQ 25.2GM BASE/PACKET POWDER / ORAL RLD 2015-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205739-004 VELTASSA EQ 1GM BASE/PACKET POWDER / ORAL RLD 2023-10-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205739-001 VELTASSA EQ 8.4GM BASE/PACKET POWDER / ORAL RLD 2015-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205739-002 VELTASSA EQ 16.8GM BASE/PACKET POWDER / ORAL RLD, RS 2015-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205739-003 VELTASSA EQ 25.2GM BASE/PACKET POWDER / ORAL RLD 2015-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205739-004 VELTASSA EQ 1GM BASE/PACKET POWDER / ORAL RLD 2023-10-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205739-001 VELTASSA EQ 8.4GM BASE/PACKET POWDER / ORAL RLD 2015-10-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205739-002 VELTASSA EQ 16.8GM BASE/PACKET POWDER / ORAL RLD, RS 2015-10-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205739-003 VELTASSA EQ 25.2GM BASE/PACKET POWDER / ORAL RLD 2015-10-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205739-004 VELTASSA EQ 1GM BASE/PACKET POWDER / ORAL RLD 2023-10-02 5bbf6a4d5a75…
Observed Orange Book patent history# Patent history page 1 of 44 · 1,725 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N205739-001 8216560 2027-03-14 U-1766 2015-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-001 8282913 2027-05-29 Drug product 2015-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-001 8147873 2028-06-20 Drug product 2015-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-001 8337824 2030-05-29 U-1766 Drug substance 2015-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-001 11123363 2033-10-08 U-1766 2021-09-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-001 9492476 2033-10-08 U-1766 2016-12-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-001 9925212 2033-10-08 U-1766 2018-04-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-002 8216560 2027-03-14 U-1766 2015-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-002 8282913 2027-05-29 Drug product 2015-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-002 8147873 2028-06-20 Drug product 2015-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-002 8337824 2030-05-29 U-1766 Drug substance 2015-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-002 11123363 2033-10-08 U-1766 2021-09-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-002 9492476 2033-10-08 U-1766 2016-12-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-002 9925212 2033-10-08 U-1766 2018-04-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-003 8216560 2027-03-14 U-1766 2015-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-003 8282913 2027-05-29 Drug product 2015-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-003 8147873 2028-06-20 Drug product 2015-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-003 8337824 2030-05-29 U-1766 Drug substance 2015-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-003 11123363 2033-10-08 U-1766 2021-09-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-003 9492476 2033-10-08 U-1766 2016-12-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-003 9925212 2033-10-08 U-1766 2018-04-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-004 8216560 2027-03-14 U-1766 2023-10-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-004 8282913 2027-05-29 Drug product 2023-10-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-004 8147873 2028-06-20 Drug product 2023-10-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-004 8337824 2030-05-29 U-1766 Drug substance 2023-10-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-004 11123363 2033-10-08 U-1766 2023-10-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-004 9492476 2033-10-08 U-1766 2023-10-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205739-004 9925212 2033-10-08 U-1766 2023-10-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 N205739-001 8216560 2027-03-14 U-1766 2015-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205739-001 8282913 2027-05-29 Drug product 2015-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205739-001 8147873 2028-06-20 Drug product 2015-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205739-001 8337824 2030-05-29 U-1766 Drug substance 2015-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205739-001 11123363 2033-10-08 U-1766 2021-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205739-001 9492476 2033-10-08 U-1766 2016-12-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205739-001 9925212 2033-10-08 U-1766 2018-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205739-002 8216560 2027-03-14 U-1766 2015-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205739-002 8282913 2027-05-29 Drug product 2015-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205739-002 8147873 2028-06-20 Drug product 2015-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205739-002 8337824 2030-05-29 U-1766 Drug substance 2015-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205739-002 11123363 2033-10-08 U-1766 2021-09-21 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 98 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 21 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 53436-084 VELTASSA patiromer Vifor Pharma, Inc. NDA Current 53436-084 VELTASSA patiromer Vifor Pharma, Inc. NDA Current 53436-084 VELTASSA patiromer Relypsa, Inc. NDA Current 53436-084 VELTASSA patiromer Vifor Pharma, Inc. NDA Current 53436-084 VELTASSA patiromer Relypsa, Inc. NDA Current 53436-084 VELTASSA patiromer Relypsa, Inc. NDA Current 53436-084 VELTASSA patiromer Vifor Pharma, Inc. NDA Current 53436-168 VELTASSA patiromer Vifor Pharma, Inc. NDA Current 53436-168 VELTASSA patiromer Vifor Pharma, Inc. NDA Current 53436-168 VELTASSA patiromer Relypsa, Inc. NDA Current 53436-168 VELTASSA patiromer Vifor Pharma, Inc. NDA Current 53436-168 VELTASSA patiromer Relypsa, Inc. NDA Current 53436-168 VELTASSA patiromer Relypsa, Inc. NDA Current 53436-168 VELTASSA patiromer Vifor Pharma, Inc. NDA Current 53436-252 VELTASSA patiromer Vifor Pharma, Inc. NDA Current 53436-252 VELTASSA patiromer Vifor Pharma, Inc. NDA Current 53436-252 VELTASSA patiromer Relypsa, Inc. NDA Current 53436-252 VELTASSA patiromer Vifor Pharma, Inc. NDA Current 53436-252 VELTASSA patiromer Relypsa, Inc. NDA Current 53436-252 VELTASSA patiromer Relypsa, Inc. NDA Current 53436-252 VELTASSA patiromer Vifor Pharma, Inc. NDA Current