Home Applications 021817 Application 021817
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RECLAST ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 5MG BASE/100ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N021817-001 RECLAST ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021817-001 AP
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021817-001 7932241 2028-02-05 Drug product 2011-05-25 N021817-001 7932241*PED 2028-08-05 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 · 44 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 2026-10-15 13:18:30 2026-09 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 c2088c7a36db…2026-09-14 22:38:34 2026-08 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021817-001 RECLAST EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2007-04-16 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Observed Orange Book patent history# Patent history page 2 of 3 · 112 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-04-04 05:41 UTC 2022-04 N021817-001 8052987 2023-10-27 U-1199 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021817-001 7932241 2028-02-05 Drug product 2011-05-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021817-001 7932241*PED 2028-08-05 Pediatric extension 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021817-001 8052987 2023-10-27 U-1199 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021817-001 7932241 2028-02-05 Drug product 2011-05-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021817-001 7932241*PED 2028-08-05 Pediatric extension 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021817-001 8052987 2023-10-27 U-1199 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021817-001 7932241 2028-02-05 Drug product 2011-05-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021817-001 7932241*PED 2028-08-05 Pediatric extension bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021817-001 8052987 2023-10-27 U-1199 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021817-001 7932241 2028-02-05 Drug product 2011-05-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021817-001 7932241*PED 2028-08-05 Pediatric extension 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021817-001 8052987 2023-10-27 U-1199 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021817-001 7932241 2028-02-05 Drug product 2011-05-25 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021817-001 7932241*PED 2028-08-05 Pediatric extension 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021817-001 8052987 2023-10-27 U-1199 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021817-001 7932241 2028-02-05 Drug product 2011-05-25 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021817-001 7932241*PED 2028-08-05 Pediatric extension 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021817-001 8052987 2023-10-27 U-1199 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021817-001 7932241 2028-02-05 Drug product 2011-05-25 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021817-001 7932241*PED 2028-08-05 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021817-001 8052987 2023-10-27 U-1199 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021817-001 7932241 2028-02-05 Drug product 2011-05-25 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021817-001 7932241*PED 2028-08-05 Pediatric extension c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021817-001 8052987 2023-10-27 U-1199 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021817-001 7932241 2028-02-05 Drug product 2011-05-25 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021817-001 7932241*PED 2028-08-05 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021817-001 8052987 2023-10-27 U-1199 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021817-001 7932241 2028-02-05 Drug product 2011-05-25 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021817-001 7932241*PED 2028-08-05 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021817-001 8052987 2023-10-27 U-1199 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021817-001 7932241 2028-02-05 Drug product 2011-05-25 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021817-001 7932241*PED 2028-08-05 Pediatric extension ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021817-001 7932241 2028-02-05 Drug product 2011-05-25 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021817-001 7932241*PED 2028-08-05 Pediatric extension 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021817-001 7932241 2028-02-05 Drug product 2011-05-25 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N021817-001 7932241*PED 2028-08-05 Pediatric extension 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021817-001 8052987 2023-10-27 U-1199 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N021817-001 7932241 2028-02-05 Drug product 2011-05-25 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N021817-001 7932241*PED 2028-08-05 Pediatric extension ea1830bbd6c7…
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 Reclast ZOLEDRONIC ACID Sandoz Inc 5a9b3737-9ce6-4a89-b76e-6aab79eba9cf 2026-02-03 Warnings, Adverse reactions Exact identifier application applno (NDA): 021817 application number: NDA021817
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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0078-0435 Reclast zoledronic acid Novartis Pharmaceuticals Corporation NDA Current 0078-0435 Reclast zoledronic acid Novartis Pharmaceuticals Corporation NDA Current 0078-0435 Reclast zoledronic acid Novartis Pharmaceuticals Corporation NDA Current 0078-0435 Reclast zoledronic acid Novartis Pharmaceuticals Corporation NDA Current 0078-0435 Reclast zoledronic acid Novartis Pharmaceuticals Corporation NDA Current