Application 202472

Type: ANDA
Sponsor: ACTAVIS INC

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/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A202472-001	ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS			2013-03-04

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 · 43 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
2026-09-14 22:38:34	2026-08	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202472-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-04	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	A202472-001	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 2 · 33 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zoledronic Acid	ZOLEDRONIC ACID	Meitheal Pharmaceuticals Inc.	8aac81ae-f92c-4f0b-b480-44badf72b5f5	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: Zoledronic Acid generic name: ZOLEDRONIC ACID
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	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	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
Zoledronic Acid	ZOLEDRONIC ACID	Dr. Reddy's Laboratories Limited	1738a682-5903-b675-3a7a-61d299a6f248	2023-10-30	Warnings, Adverse reactions	Name fallback brand name: Zoledronic Acid generic name: ZOLEDRONIC ACID

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45963-440	Zoledronic Acid	Zoledronic Acid	Actavis Pharma, Inc.	ANDA	Current
45963-440	Zoledronic Acid	Zoledronic Acid	Actavis Pharma, Inc.	ANDA	Current