Application 020036

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AREDIA	PAMIDRONATE DISODIUM	INJECTABLE;INJECTION	30MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	AREDIA	PAMIDRONATE DISODIUM	INJECTABLE;INJECTION	60MG/VIAL	No	No
004	AREDIA	PAMIDRONATE DISODIUM	INJECTABLE;INJECTION	90MG/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N020036-001	AREDIA	PAMIDRONATE DISODIUM	30MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-31
N020036-003	AREDIA	PAMIDRONATE DISODIUM	60MG/VIAL	INJECTABLE / INJECTION		1993-05-06
N020036-004	AREDIA	PAMIDRONATE DISODIUM	90MG/VIAL	INJECTABLE / INJECTION		1993-05-06

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 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2020-11-12 02:37 UTC	2020-11	N020036-004	AREDIA	90MG/VIAL	INJECTABLE / INJECTION		1993-05-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020036-001	AREDIA	30MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1991-10-31	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020036-003	AREDIA	60MG/VIAL	INJECTABLE / INJECTION		1993-05-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020036-004	AREDIA	90MG/VIAL	INJECTABLE / INJECTION		1993-05-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020036-001	AREDIA	30MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1991-10-31	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020036-003	AREDIA	60MG/VIAL	INJECTABLE / INJECTION		1993-05-06	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020036-004	AREDIA	90MG/VIAL	INJECTABLE / INJECTION		1993-05-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020036-001	AREDIA	30MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1991-10-31	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020036-003	AREDIA	60MG/VIAL	INJECTABLE / INJECTION		1993-05-06	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020036-004	AREDIA	90MG/VIAL	INJECTABLE / INJECTION		1993-05-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020036-001	AREDIA	30MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-31	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020036-003	AREDIA	60MG/VIAL	INJECTABLE / INJECTION		1993-05-06	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020036-004	AREDIA	90MG/VIAL	INJECTABLE / INJECTION		1993-05-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020036-001	AREDIA	30MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-31	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020036-003	AREDIA	60MG/VIAL	INJECTABLE / INJECTION		1993-05-06	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020036-004	AREDIA	90MG/VIAL	INJECTABLE / INJECTION		1993-05-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020036-001	AREDIA	30MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-31	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020036-003	AREDIA	60MG/VIAL	INJECTABLE / INJECTION		1993-05-06	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020036-004	AREDIA	90MG/VIAL	INJECTABLE / INJECTION		1993-05-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020036-001	AREDIA	30MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-31	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020036-003	AREDIA	60MG/VIAL	INJECTABLE / INJECTION		1993-05-06	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020036-004	AREDIA	90MG/VIAL	INJECTABLE / INJECTION		1993-05-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020036-001	AREDIA	30MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-31	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020036-003	AREDIA	60MG/VIAL	INJECTABLE / INJECTION		1993-05-06	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020036-004	AREDIA	90MG/VIAL	INJECTABLE / INJECTION		1993-05-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020036-001	AREDIA	30MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-31	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020036-003	AREDIA	60MG/VIAL	INJECTABLE / INJECTION		1993-05-06	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020036-004	AREDIA	90MG/VIAL	INJECTABLE / INJECTION		1993-05-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020036-001	AREDIA	30MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-31	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020036-003	AREDIA	60MG/VIAL	INJECTABLE / INJECTION		1993-05-06	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020036-004	AREDIA	90MG/VIAL	INJECTABLE / INJECTION		1993-05-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020036-001	AREDIA	30MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-31	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020036-003	AREDIA	60MG/VIAL	INJECTABLE / INJECTION		1993-05-06	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020036-004	AREDIA	90MG/VIAL	INJECTABLE / INJECTION		1993-05-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020036-001	AREDIA	30MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-31	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020036-003	AREDIA	60MG/VIAL	INJECTABLE / INJECTION		1993-05-06	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020036-004	AREDIA	90MG/VIAL	INJECTABLE / INJECTION		1993-05-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020036-001	AREDIA	30MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-31	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020036-003	AREDIA	60MG/VIAL	INJECTABLE / INJECTION		1993-05-06	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020036-004	AREDIA	90MG/VIAL	INJECTABLE / INJECTION		1993-05-06	`3a93d1ddd44b…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pamidronate Disodium	PAMIDRONATE DISODIUM	Hospira, Inc.	9b6a9a3b-71c9-4dcb-b857-5d1de25c3a23	2026-05-14	Warnings, Adverse reactions	Name fallback generic name: PAMIDRONATE DISODIUM
Pamidronate Disodium	PAMIDRONATE DISODIUM	Mylan Institutional LLC	c2ca033e-fa5f-4141-b702-11f8b4303da1	2025-12-15	Warnings, Adverse reactions	Name fallback generic name: PAMIDRONATE DISODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
21070	SUPPL	2012-06-07
12158	SUPPL	2012-06-06
34201	SUPPL	2011-04-11
1944	SUPPL	2011-04-04
41131	SUPPL	2009-01-12
12157	SUPPL	2009-01-02
21069	SUPPL	2008-12-18
20459	SUPPL	2008-02-19
21068	SUPPL	2008-01-09
23564	ORIG	2008-01-07
12156	SUPPL	2007-12-14
20461	SUPPL	2007-08-06
12155	SUPPL	2005-11-18
1943	SUPPL	2005-11-18
12154	SUPPL	2005-10-14
1942	SUPPL	2005-10-14
12153	SUPPL	2005-02-03
1941	SUPPL	2005-02-03
1936	SUPPL	2004-09-10
20460	SUPPL	2004-05-27
1940	SUPPL	2004-03-28
21067	SUPPL	2004-01-09
41128	SUPPL	2004-01-06
41127	SUPPL	2004-01-06
41126	SUPPL	2004-01-06
20458	SUPPL	2004-01-06
20457	SUPPL	2004-01-06
20456	ORIG	2004-01-06
34199	ORIG	2003-12-02
21064	ORIG	2003-12-02
21065	SUPPL	2003-10-16
34200	SUPPL	2003-04-30
1939	SUPPL	2002-07-12
21066	SUPPL	2001-08-20
12152	SUPPL	2001-08-20
41130	SUPPL	1998-09-22
41129	SUPPL	1998-09-22
1938	SUPPL	1998-09-22
1937	SUPPL	1998-09-22