Application 201801

Type: ANDA
Sponsor: EMCURE PHARMS 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 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
A201801-001	ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS			2013-03-29

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2013-03-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2013-03-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2013-03-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2013-03-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201801-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2013-03-29	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A201801-001	AP	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A201801-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201801-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201801-001	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 2 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	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
Zoledronic acid	ZOLEDRONIC ACID	Mylan Institutional LLC	20cd29cc-cef5-48c4-adfe-6b3dfee0ab61	2023-10-18	Warnings, Adverse reactions	Name fallback brand name: Zoledronic acid generic name: ZOLEDRONIC ACID
Zoledronic Acid	ZOLEDRONIC ACID	Fresenius Kabi USA, LLC	16fcf8c9-ef8a-4e93-9ee6-acfadd35a861	2023-09-21	Warnings, Adverse reactions	Name fallback brand name: Zoledronic Acid generic name: ZOLEDRONIC ACID
Zoledronic acid	ZOLEDRONIC ACID	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	00a5bd5a-e5ee-4bad-b510-a4d4485485c8	2023-09-18	Warnings, Adverse reactions	Name fallback brand name: Zoledronic acid generic name: ZOLEDRONIC ACID
Zoledronic acid	ZOLEDRONIC ACID	NORTHSTAR RX LLC	3885488c-6b83-421b-afee-61abceb95634	2023-09-06	Warnings, Adverse reactions	Name fallback brand name: Zoledronic acid generic name: ZOLEDRONIC ACID
Zoledronic Acid	ZOLEDRONIC ACID	Fresenius Kabi USA, LLC	f3f9de47-3d85-4d0c-a29e-1635cad3a970	2023-08-24	Warnings, Adverse reactions	Name fallback brand name: Zoledronic Acid generic name: ZOLEDRONIC ACID
Zoledronic acid	ZOLEDRONIC ACID	BluePoint Laboratories	666b1833-ee9b-4a6f-bd4c-9526552cec0a	2023-07-27	Warnings, Adverse reactions	Name fallback brand name: Zoledronic acid generic name: ZOLEDRONIC ACID
Zoledronic Acid	ZOLEDRONIC ACID	Meitheal Pharmaceuticals Inc.	8aac81ae-f92c-4f0b-b480-44badf72b5f5	2023-06-12	Warnings, Adverse reactions	Name fallback brand name: Zoledronic Acid generic name: ZOLEDRONIC ACID
Zoledronic Acid	ZOLEDRONIC ACID	Westminster Pharmaceuticals, LLC	6a153c94-3cb5-4c05-98b2-1e18f5f3fe80	2023-02-02	Warnings, Adverse reactions	Name fallback brand name: Zoledronic Acid generic name: ZOLEDRONIC ACID
Zoledronic Acid	ZOLEDRONIC ACID	AuroMedics Pharma LLC	ac7ff1eb-6e73-4cc8-9114-c5a4483ad4c3	2021-11-29	Warnings, Adverse reactions	Name fallback brand name: Zoledronic Acid generic name: ZOLEDRONIC ACID
zoledronic acid	ZOLEDRONIC ACID	Sagent Pharmaceuticals	deb89be7-f40e-4fd4-a2cb-96634b45da84	2021-09-20	Warnings, Adverse reactions	Name fallback brand name: zoledronic acid generic name: ZOLEDRONIC ACID
Zoledronic Acid	ZOLEDRONIC ACID	Hikma Pharmaceuticals USA Inc.	784d33fa-0046-42eb-894b-3fc47dcfd4dc	2021-01-01	Warnings, Adverse reactions	Name fallback brand name: Zoledronic Acid generic name: ZOLEDRONIC ACID
Zoledronic Acid	ZOLEDRONIC ACID	Gland Pharma Limited	1740d7d8-a101-4688-8d8b-beb00559d602	2019-04-02	Warnings, Adverse reactions	Name fallback brand name: Zoledronic Acid generic name: ZOLEDRONIC ACID
Zoledronic acid	ZOLEDRONIC ACID	Dr. Reddy's Laboratories Inc	b165df31-52f0-d67f-71e7-f3b4f18d2f15	2018-05-16	Warnings, Adverse reactions	Name fallback brand name: Zoledronic acid generic name: ZOLEDRONIC ACID
Zoledronic Acid	ZOLEDRONIC ACID	Dr.Reddy's Laboratories Inc	c8e02635-4473-8ba2-248f-ced58dbeabce	2017-07-20	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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23155-186	Zoledronic acid	Zoledronic acid	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-525	Zoledronic acid	Zoledronic acid	Heritage Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22860	ORIG	2013-05-02