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 3 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 2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021817-001 8052987 2023-10-27 U-1199 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021817-001 7932241 2028-02-05 Drug product 2011-05-25 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021817-001 7932241*PED 2028-08-05 Pediatric extension a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021817-001 8052987 2023-10-27 U-1199 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021817-001 7932241 2028-02-05 Drug product 2011-05-25 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021817-001 7932241*PED 2028-08-05 Pediatric extension 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021817-001 8052987 2023-10-27 U-1199 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021817-001 7932241 2028-02-05 Drug product 2011-05-25 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021817-001 7932241*PED 2028-08-05 Pediatric extension a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021817-001 8052987 2023-10-27 U-1199 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021817-001 7932241 2028-02-05 Drug product 2011-05-25 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021817-001 7932241*PED 2028-08-05 Pediatric extension 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021817-001 8052987 2023-10-27 U-1199 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N021817-001 7932241 2028-02-05 Drug product 2011-05-25 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N021817-001 7932241*PED 2028-08-05 Pediatric extension 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021817-001 8052987 2023-10-27 U-1199 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N021817-001 7932241 2028-02-05 Drug product 2011-05-25 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N021817-001 7932241*PED 2028-08-05 Pediatric extension 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021817-001 8052987 2023-10-27 U-1199 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021817-001 7932241 2028-02-05 Drug product 2011-05-25 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021817-001 7932241*PED 2028-08-05 Pediatric extension 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021817-001 8052987 2023-10-27 U-1199 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021817-001 7932241 2028-02-05 Drug product 2011-05-25 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021817-001 7932241*PED 2028-08-05 Pediatric extension f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021817-001 8052987 2023-10-27 U-1199 e64feba35796…2022-09-29 23:25 UTC 2022-09 N021817-001 7932241 2028-02-05 Drug product 2011-05-25 e64feba35796…2022-09-29 23:25 UTC 2022-09 N021817-001 7932241*PED 2028-08-05 Pediatric extension e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021817-001 8052987 2023-10-27 U-1199 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021817-001 7932241 2028-02-05 Drug product 2011-05-25 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021817-001 7932241*PED 2028-08-05 Pediatric extension cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021817-001 7932241 2028-02-05 Drug product 2011-05-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021817-001 7932241*PED 2028-08-05 Pediatric extension a50c72e98297…
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