Home Applications 202163 Application 202163
Type ANDA
Sponsor BRECKENRIDGE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 5MG BASE/100ML No No
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 A202163-001 ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202163-001 AP
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 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202163-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-05 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 2 · 35 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Zoledronic Acid ZOLEDRONIC ACID Eugia US LLC bf5f96d4-f87c-4968-bed0-a4b5e77f4162 2026-05-15 Warnings, Adverse reactions Name fallback brand name: Zoledronic Acid generic name: ZOLEDRONIC ACID Zoledronic acid ZOLEDRONIC ACID BluePoint Laboratories 5de65a7f-a219-4b22-9155-61fedc84433b 2026-04-13 Warnings, Adverse reactions Name fallback brand name: Zoledronic acid generic name: ZOLEDRONIC ACID Zoledronic Acid ZOLEDRONIC ACID Mylan Institutional LLC 80006f10-85a3-4390-b5dc-3b2097134f3d 2026-03-18 Warnings, Adverse reactions Name fallback brand name: Zoledronic Acid generic name: ZOLEDRONIC ACID Zoledronic Acid ZOLEDRONIC ACID Mylan Institutional LLC 1977d713-4cc7-405e-b4c1-a9a91635eff6 2026-03-16 Warnings, Adverse reactions Name fallback brand name: Zoledronic Acid generic name: ZOLEDRONIC ACID Zoledronic acid ZOLEDRONIC ACID Gland Pharma Limited d761011b-edd6-4d3f-bacd-8607dc2414fc 2026-02-27 Warnings, Adverse reactions Name fallback brand name: Zoledronic acid generic name: ZOLEDRONIC ACID Zoledronic acid ZOLEDRONIC ACID FOSUN PHARMA USA INC fd0324d8-b9bd-fd4c-e053-6394a90a5465 2026-02-26 Warnings, Adverse reactions Name fallback brand name: Zoledronic acid generic name: ZOLEDRONIC ACID Zoledronic Acid ZOLEDRONIC ACID Gland Pharma Limited 824eaeee-6b3d-4d62-b268-77f8bd8e7f10 2026-02-24 Warnings, Adverse reactions Name fallback brand name: Zoledronic Acid generic name: ZOLEDRONIC ACID zoledronic acid ZOLEDRONIC ACID Gland Pharma Limited 46c3a880-3723-45cf-979e-57ef6391662e 2026-02-06 Warnings, Adverse reactions Name fallback brand name: zoledronic acid generic name: ZOLEDRONIC ACID Reclast ZOLEDRONIC ACID Sandoz Inc 5a9b3737-9ce6-4a89-b76e-6aab79eba9cf 2026-02-03 Warnings, Adverse reactions Name fallback generic name: ZOLEDRONIC ACID Zoledronic Acid ZOLEDRONIC ACID BPI Labs LLC 1b556f75-9174-4798-8c8d-21cf34beac13 2025-12-26 Warnings, Adverse reactions Name fallback brand name: Zoledronic Acid generic name: ZOLEDRONIC ACID Zoledronic acid ZOLEDRONIC ACID Accord Healthcare Inc. 3df715a1-2562-4374-a383-6edc33c6e52f 2025-10-08 Warnings, Adverse reactions Name fallback brand name: Zoledronic acid generic name: ZOLEDRONIC ACID Zoledronic Acid ZOLEDRONIC ACID BPI Labs LLC 634e9d4b-e940-4743-ad39-794dad28d79b 2025-10-03 Warnings, Adverse reactions Name fallback brand name: Zoledronic Acid generic name: ZOLEDRONIC ACID Zoledronic acid ZOLEDRONIC ACID BluePoint Laboratories f433c13c-dd8c-4dca-834e-a4ecf09d1eab 2025-09-03 Warnings, Adverse reactions Name fallback brand name: Zoledronic acid generic name: ZOLEDRONIC ACID zoledronic acid ZOLEDRONIC ACID Sagent Pharmaceuticals 567578e6-cd2d-4339-b0f6-7a15444c0639 2025-03-11 Warnings, Adverse reactions Name fallback brand name: zoledronic acid generic name: ZOLEDRONIC ACID zoledronic acid ZOLEDRONIC ACID Sagent Pharmaceuticals 164500d7-51cf-438a-8bee-7a7dce76ad7a 2025-03-11 Warnings, Adverse reactions Name fallback brand name: zoledronic acid generic name: ZOLEDRONIC ACID Zoledronic Acid ZOLEDRONIC ACID Avenacy Inc. 4b699dd8-d232-4bdb-88ce-9b42ed93e036 2025-01-15 Warnings, Adverse reactions Name fallback brand name: Zoledronic Acid generic name: ZOLEDRONIC ACID Zoledronic Acid ZOLEDRONIC ACID Dr.Reddy's Laboratories Ltd f94a5c9e-74bc-d09e-cd65-394b2a5de2ad 2024-11-01 Warnings, Adverse reactions Name fallback brand name: Zoledronic Acid generic name: ZOLEDRONIC ACID Zoledronic Acid ZOLEDRONIC ACID Gland Pharma Limited 7a5e8962-7c4b-40bb-ad69-0c3edb0338af 2023-11-15 Warnings, Adverse reactions Name fallback brand name: Zoledronic Acid generic name: ZOLEDRONIC ACID Zoledronic Acid ZOLEDRONIC ACID Dr. Reddy's Laboratories Inc. bbb29627-76b5-e742-0e79-ef3bf22021b8 2023-10-30 Warnings, Adverse reactions Name fallback brand name: Zoledronic Acid generic name: ZOLEDRONIC ACID Zoledronic Acid ZOLEDRONIC ACID Dr. Reddy's Laboratories Inc. 72623e70-9db3-f1b8-de7d-c1a61d71fb01 2023-10-30 Warnings, Adverse reactions Name fallback brand name: Zoledronic Acid generic name: ZOLEDRONIC ACID
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 42023-163 Zoledronic Acid Zoledronic Acid Par Pharmaceutical Companies, Inc. ANDA Current 51991-064 Zoledronic Acid Zoledronic Acid Breckenridge Pharmaceutical, Inc ANDA Current 51991-064 Zoledronic Acid Zoledronic Acid Breckenridge Pharmaceutical, Inc ANDA Current