Application 203231

Type: NDA
Sponsor: INFORLIFE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZOLEDRONIC ACID	ZOLEDRONIC ACID	INJECTABLE;INTRAVENOUS	EQ 4MG BASE/100ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N203231-001	ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2013-08-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N203231-001	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 · 42 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
2026-08-18 06:07:40	2026-07	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2013-08-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2013-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2013-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2013-08-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2013-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2013-08-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2013-08-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2013-08-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2013-08-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2013-08-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2013-08-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2013-08-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2013-08-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2013-08-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2013-08-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP		2013-08-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP		2013-08-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP		2013-08-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP		2013-08-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP		2013-08-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP		2013-08-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP		2013-08-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP		2013-08-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP		2013-08-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP		2013-08-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP		2013-08-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP		2013-08-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP		2013-08-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2013-08-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2013-08-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2013-08-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	RLD	2013-08-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	RLD	2013-08-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP		2013-08-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP		2013-08-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP		2013-08-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP		2013-08-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP		2013-08-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP		2013-08-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203231-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP		2013-08-02	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N203231-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203231-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203231-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203231-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203231-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203231-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203231-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203231-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203231-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203231-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203231-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203231-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203231-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203231-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203231-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203231-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203231-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203231-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203231-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203231-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203231-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203231-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203231-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203231-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203231-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203231-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203231-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203231-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203231-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203231-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203231-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203231-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203231-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203231-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203231-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203231-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203231-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203231-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203231-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203231-001	AP	1	`e64feba35796…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
zoledronic acid	ZOLEDRONIC ACID	Sagent Pharmaceuticals	567578e6-cd2d-4339-b0f6-7a15444c0639	2025-03-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203231 application number: NDA203231 ndc (product): 25021-826
zoledronic acid	ZOLEDRONIC ACID	Sagent Pharmaceuticals	deb89be7-f40e-4fd4-a2cb-96634b45da84	2021-09-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203231 application number: NDA203231 ndc (product): 25021-826

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25021-826	zoledronic acid	zoledronic acid	Sagent Pharmaceuticals	NDA	Current
25021-826	zoledronic acid	zoledronic acid	Sagent Pharmaceuticals	NDA	Current
25021-826	zoledronic acid	zoledronic acid	Sagent Pharmaceuticals	NDA	Current
25021-826	zoledronic acid	zoledronic acid	Sagent Pharmaceuticals	NDA	Current
25021-826	zoledronic acid	zoledronic acid	Sagent Pharmaceuticals	NDA	Current
25021-826	zoledronic acid	zoledronic acid	Sagent Pharmaceuticals	NDA	Current
25021-826	zoledronic acid	zoledronic acid	Sagent Pharmaceuticals	NDA	Current
25021-826	zoledronic acid	zoledronic acid	Sagent Pharmaceuticals	NDA	Current
25021-826	zoledronic acid	zoledronic acid	Sagent Pharmaceuticals	NDA	Current
25021-826	zoledronic acid	zoledronic acid	Sagent Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70707	SUPPL	2022-04-06
70705	SUPPL	2022-04-06
65112	SUPPL	2020-10-30
65111	SUPPL	2020-10-30
65110	SUPPL	2020-10-30
65070	SUPPL	2020-10-29
65069	SUPPL	2020-10-29
47094	SUPPL	2017-02-03
47093	SUPPL	2017-02-03
19451	SUPPL	2016-03-29
10192	SUPPL	2016-03-29
40281	SUPPL	2015-10-15
32400	SUPPL	2015-10-13
32399	SUPPL	2014-12-12
32398	SUPPL	2014-12-12
10191	SUPPL	2014-12-12
40280	SUPPL	2014-12-11
40279	SUPPL	2014-12-11
19450	SUPPL	2014-12-11
40278	SUPPL	2014-05-06
32397	SUPPL	2014-05-06
22917	ORIG	2014-04-17
19449	ORIG	2013-08-06
10190	ORIG	2013-08-05
32396	ORIG	2012-11-13