Application 204344

Type: ANDA
Sponsor: DR REDDYS LABS LTD

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 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
A204344-001	ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS			2018-11-19

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2018-11-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2018-11-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204344-001	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS		2018-11-19	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A204344-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204344-001	AP	1	`ea99ee380514…`

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
Zoledronic acid	ZOLEDRONIC ACID	Dr. Reddy's Laboratories Inc	b165df31-52f0-d67f-71e7-f3b4f18d2f15	2018-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204344 application number: ANDA204344 ndc (product): 43598-255

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43598-255	Zoledronic acid	Zoledronic acid	Dr. Reddy's Laboratories Inc	ANDA	Current