Application 021223

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZOMETA	ZOLEDRONIC ACID	INJECTABLE;INTRAVENOUS	EQ 4MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	ZOMETA	ZOLEDRONIC ACID	INJECTABLE;INTRAVENOUS	EQ 4MG BASE/5ML	Yes	Yes
003	ZOMETA	ZOLEDRONIC ACID	INJECTABLE;INTRAVENOUS	EQ 4MG BASE/100ML	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021223-001	ZOMETA	ZOLEDRONIC ACID	EQ 4MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2001-08-20
N021223-002	ZOMETA	ZOLEDRONIC ACID	EQ 4MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2003-03-07
N021223-003	ZOMETA	ZOLEDRONIC ACID	EQ 4MG BASE/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2011-06-17

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021223-003	7932241	2028-02-05		Drug product	2011-06-30

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021223-001	ZOMETA	EQ 4MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2001-08-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021223-002	ZOMETA	EQ 4MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2003-03-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021223-003	ZOMETA	EQ 4MG BASE/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2011-06-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021223-001	ZOMETA	EQ 4MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2001-08-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021223-002	ZOMETA	EQ 4MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2003-03-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021223-003	ZOMETA	EQ 4MG BASE/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2011-06-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021223-001	ZOMETA	EQ 4MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2001-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021223-002	ZOMETA	EQ 4MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2003-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021223-003	ZOMETA	EQ 4MG BASE/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2011-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021223-001	ZOMETA	EQ 4MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2001-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021223-002	ZOMETA	EQ 4MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2003-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021223-003	ZOMETA	EQ 4MG BASE/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2011-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021223-001	ZOMETA	EQ 4MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2001-08-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021223-002	ZOMETA	EQ 4MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2003-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021223-003	ZOMETA	EQ 4MG BASE/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2011-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021223-001	ZOMETA	EQ 4MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2001-08-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021223-002	ZOMETA	EQ 4MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2003-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021223-003	ZOMETA	EQ 4MG BASE/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2011-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021223-001	ZOMETA	EQ 4MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2001-08-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021223-002	ZOMETA	EQ 4MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2003-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021223-003	ZOMETA	EQ 4MG BASE/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2011-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021223-001	ZOMETA	EQ 4MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2001-08-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021223-002	ZOMETA	EQ 4MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2003-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021223-003	ZOMETA	EQ 4MG BASE/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2011-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021223-001	ZOMETA	EQ 4MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2001-08-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021223-002	ZOMETA	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	RLD	2003-03-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021223-003	ZOMETA	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	RLD	2011-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021223-001	ZOMETA	EQ 4MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2001-08-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021223-002	ZOMETA	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	RLD	2003-03-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021223-003	ZOMETA	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	RLD	2011-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021223-001	ZOMETA	EQ 4MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2001-08-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021223-002	ZOMETA	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	RLD	2003-03-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021223-003	ZOMETA	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	RLD	2011-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021223-001	ZOMETA	EQ 4MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2001-08-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021223-002	ZOMETA	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	RLD	2003-03-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021223-003	ZOMETA	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	RLD	2011-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021223-001	ZOMETA	EQ 4MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2001-08-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021223-002	ZOMETA	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	RLD	2003-03-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021223-003	ZOMETA	EQ 4MG BASE/100ML	INJECTABLE / INTRAVENOUS	RLD	2011-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021223-001	ZOMETA	EQ 4MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2001-08-20	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021223-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021223-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021223-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021223-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021223-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021223-003	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021223-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021223-003	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021223-002	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021223-003	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021223-002	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021223-003	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021223-002	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021223-003	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021223-002	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021223-003	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021223-002	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021223-003	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021223-002	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021223-003	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021223-002	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021223-003	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021223-002	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021223-003	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021223-002	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021223-003	AP	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N021223-002	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021223-003	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021223-002	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021223-003	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021223-002	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021223-003	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021223-002	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021223-003	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021223-002	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021223-003	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021223-002	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021223-003	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021223-002	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021223-003	AP	1	`3bdfa0b2c4d7…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 355 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021223-003	7932241	2028-02-05		Drug product	2011-06-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021223-003	7932241	2028-02-05		Drug product	2011-06-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021223-003	7932241	2028-02-05		Drug product	2011-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021223-002	8324189	2025-05-29	U-1308		2012-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021223-002	8324189	2025-05-29	U-1309		2012-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021223-002	8324189	2025-05-29	U-53		2012-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021223-002	8324189*PED	2025-11-29		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021223-003	8324189	2025-05-29	U-1308		2012-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021223-003	8324189	2025-05-29	U-1309		2012-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021223-003	8324189	2025-05-29	U-53		2012-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021223-003	8324189*PED	2025-11-29		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021223-003	7932241	2028-02-05		Drug product	2011-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021223-002	8324189	2025-05-29	U-1308		2012-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021223-002	8324189	2025-05-29	U-1309		2012-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021223-002	8324189	2025-05-29	U-53		2012-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021223-002	8324189*PED	2025-11-29		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021223-003	8324189	2025-05-29	U-1308		2012-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021223-003	8324189	2025-05-29	U-1309		2012-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021223-003	8324189	2025-05-29	U-53		2012-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021223-003	8324189*PED	2025-11-29		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021223-003	7932241	2028-02-05		Drug product	2011-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021223-002	8324189	2025-05-29	U-1308		2012-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021223-002	8324189	2025-05-29	U-1309		2012-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021223-002	8324189	2025-05-29	U-53		2012-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021223-002	8324189*PED	2025-11-29		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021223-003	8324189	2025-05-29	U-1308		2012-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021223-003	8324189	2025-05-29	U-1309		2012-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021223-003	8324189	2025-05-29	U-53		2012-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021223-003	8324189*PED	2025-11-29		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021223-003	7932241	2028-02-05		Drug product	2011-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021223-002	8324189	2025-05-29	U-1308		2012-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021223-002	8324189	2025-05-29	U-1309		2012-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021223-002	8324189	2025-05-29	U-53		2012-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021223-002	8324189*PED	2025-11-29		Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021223-003	8324189	2025-05-29	U-1308		2012-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021223-003	8324189	2025-05-29	U-1309		2012-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021223-003	8324189	2025-05-29	U-53		2012-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021223-003	8324189*PED	2025-11-29		Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021223-003	7932241	2028-02-05		Drug product	2011-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021223-002	8324189	2025-05-29	U-1308		2012-12-21	`03ed91905a0d…`

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 · 33 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zoledronic acid	ZOLEDRONIC ACID	Mylan Institutional LLC	20cd29cc-cef5-48c4-adfe-6b3dfee0ab61	2023-10-18	Warnings, Adverse reactions	Name fallback 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 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 generic name: ZOLEDRONIC ACID
Zoledronic acid	ZOLEDRONIC ACID	NORTHSTAR RX LLC	3885488c-6b83-421b-afee-61abceb95634	2023-09-06	Warnings, Adverse reactions	Name fallback 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 generic name: ZOLEDRONIC ACID
Zoledronic acid	ZOLEDRONIC ACID	BluePoint Laboratories	666b1833-ee9b-4a6f-bd4c-9526552cec0a	2023-07-27	Warnings, Adverse reactions	Name fallback generic name: ZOLEDRONIC ACID
Zoledronic Acid	ZOLEDRONIC ACID	Westminster Pharmaceuticals, LLC	6a153c94-3cb5-4c05-98b2-1e18f5f3fe80	2023-02-02	Warnings, Adverse reactions	Name fallback generic name: ZOLEDRONIC ACID
Zoledronic Acid	ZOLEDRONIC ACID	AuroMedics Pharma LLC	ac7ff1eb-6e73-4cc8-9114-c5a4483ad4c3	2021-11-29	Warnings, Adverse reactions	Name fallback generic name: ZOLEDRONIC ACID
zoledronic acid	ZOLEDRONIC ACID	Sagent Pharmaceuticals	deb89be7-f40e-4fd4-a2cb-96634b45da84	2021-09-20	Warnings, Adverse reactions	Name fallback 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 generic name: ZOLEDRONIC ACID
Zoledronic Acid	ZOLEDRONIC ACID	Gland Pharma Limited	1740d7d8-a101-4688-8d8b-beb00559d602	2019-04-02	Warnings, Adverse reactions	Name fallback 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 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 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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0387	Zometa	zoledronic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0387	Zometa	zoledronic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0387	Zometa	zoledronic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0387	Zometa	zoledronic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0590	Zometa	zoledronic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0590	Zometa	zoledronic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0590	Zometa	zoledronic acid	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57147	SUPPL	2019-01-09
56912	SUPPL	2018-12-21
46596	SUPPL	2016-12-30
46586	SUPPL	2016-12-29
27108	SUPPL	2016-04-04
36382	SUPPL	2016-03-31
36381	SUPPL	2015-06-11
4666	SUPPL	2015-06-10
14661	SUPPL	2015-01-08
27107	SUPPL	2015-01-07
27106	SUPPL	2014-04-08
14660	SUPPL	2014-04-08
36380	SUPPL	2013-10-01
27105	SUPPL	2013-10-01
36379	SUPPL	2012-11-15
4665	SUPPL	2012-11-14
36378	SUPPL	2012-03-16
27104	SUPPL	2012-03-16
27103	SUPPL	2010-01-25
14659	SUPPL	2009-11-17
42035	SUPPL	2008-08-01
14658	SUPPL	2008-03-24
27102	SUPPL	2008-03-21
27101	SUPPL	2007-11-08
27100	SUPPL	2007-11-08
14657	SUPPL	2007-11-07
36377	SUPPL	2006-05-26
4664	SUPPL	2006-05-26
27099	SUPPL	2005-10-14
14656	SUPPL	2005-10-14
36376	SUPPL	2005-02-03
27098	SUPPL	2005-02-03
27097	SUPPL	2005-02-03
14655	SUPPL	2005-02-03
14654	SUPPL	2004-04-05
27096	SUPPL	2004-03-28
36375	SUPPL	2004-03-25
4663	SUPPL	2004-03-02
23634	ORIG	2003-12-12
14653	SUPPL	2003-03-26
4662	SUPPL	2003-03-26
42034	SUPPL	2002-02-22
14652	SUPPL	2002-02-22
4661	SUPPL	2002-02-22
36374	ORIG	2001-08-20
27095	ORIG	2001-08-20
21517	ORIG	2001-08-20
53444	ORIG	1900-01-01
53443	ORIG	1900-01-01
53442	ORIG	1900-01-01
52394	ORIG	1900-01-01