Application 209578

Type: ANDA
Sponsor: GLAND PHARMA LTD

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
A209578-001	ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP		2019-08-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209578-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209578-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2019-08-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209578-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209578-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209578-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209578-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209578-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209578-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209578-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209578-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209578-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209578-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209578-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209578-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209578-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209578-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209578-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209578-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209578-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209578-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209578-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209578-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209578-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209578-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209578-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209578-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209578-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209578-001	AP	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209578-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209578-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209578-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209578-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209578-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209578-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209578-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209578-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209578-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209578-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209578-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209578-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209578-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209578-001	AP	1	`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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zoledronic acid	ZOLEDRONIC ACID	BluePoint Laboratories	5de65a7f-a219-4b22-9155-61fedc84433b	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209578 application number: ANDA209578
Zoledronic acid	ZOLEDRONIC ACID	Gland Pharma Limited	d761011b-edd6-4d3f-bacd-8607dc2414fc	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209578 application number: ANDA209578 ndc (product): 68083-256
Zoledronic acid	ZOLEDRONIC ACID	FOSUN PHARMA USA INC	fd0324d8-b9bd-fd4c-e053-6394a90a5465	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209578 application number: ANDA209578

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68083-256	Zoledronic acid	Zoledronic acid	Gland Pharma Limited	ANDA	Current
68083-256	Zoledronic acid	Zoledronic acid	Gland Pharma Limited	ANDA	Current
70860-802	Zoledronic Acid	zoledronic acid	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-802	Zoledronic Acid	zoledronic acid	Athenex Pharmaceutical Division, LLC.	ANDA	Current