Application 020649

Type: NDA
Sponsor: AUXILIUM PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EDEX	ALPROSTADIL	INJECTABLE;INJECTION	0.005MG/VIAL	No	No
002	EDEX	ALPROSTADIL	INJECTABLE;INJECTION	0.01MG/VIAL	Yes	No
003	EDEX	ALPROSTADIL	INJECTABLE;INJECTION	0.02MG/VIAL	Yes	No
004	EDEX	ALPROSTADIL	INJECTABLE;INJECTION	0.04MG/VIAL	Yes	Yes
005	EDEX	ALPROSTADIL	INJECTABLE;INJECTION	0.01MG/VIAL	Yes	Yes
006	EDEX	ALPROSTADIL	INJECTABLE;INJECTION	0.02MG/VIAL	Yes	Yes
007	EDEX	ALPROSTADIL	INJECTABLE;INJECTION	0.04MG/VIAL	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020649-001	EDEX	ALPROSTADIL	0.005MG/VIAL	INJECTABLE / INJECTION			1997-06-12
N020649-002	EDEX	ALPROSTADIL	0.01MG/VIAL	INJECTABLE / INJECTION	AP	RLD	1997-06-12
N020649-003	EDEX	ALPROSTADIL	0.02MG/VIAL	INJECTABLE / INJECTION	AP	RLD	1997-06-12
N020649-004	EDEX	ALPROSTADIL	0.04MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-06-12
N020649-005	EDEX	ALPROSTADIL	0.01MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30
N020649-006	EDEX	ALPROSTADIL	0.02MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30
N020649-007	EDEX	ALPROSTADIL	0.04MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N020649-002	AP
N020649-003	AP
N020649-004	AP

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 8 · 294 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020649-001	EDEX	0.005MG/VIAL	INJECTABLE / INJECTION			1997-06-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020649-002	EDEX	0.01MG/VIAL	INJECTABLE / INJECTION	AP	RLD	1997-06-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020649-003	EDEX	0.02MG/VIAL	INJECTABLE / INJECTION	AP	RLD	1997-06-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020649-004	EDEX	0.04MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-06-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020649-005	EDEX	0.01MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020649-006	EDEX	0.02MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020649-007	EDEX	0.04MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020649-001	EDEX	0.005MG/VIAL	INJECTABLE / INJECTION			1997-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020649-002	EDEX	0.01MG/VIAL	INJECTABLE / INJECTION	AP	RLD	1997-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020649-003	EDEX	0.02MG/VIAL	INJECTABLE / INJECTION	AP	RLD	1997-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020649-004	EDEX	0.04MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020649-005	EDEX	0.01MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020649-006	EDEX	0.02MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020649-007	EDEX	0.04MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020649-001	EDEX	0.005MG/VIAL	INJECTABLE / INJECTION			1997-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020649-002	EDEX	0.01MG/VIAL	INJECTABLE / INJECTION	AP	RLD	1997-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020649-003	EDEX	0.02MG/VIAL	INJECTABLE / INJECTION	AP	RLD	1997-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020649-004	EDEX	0.04MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020649-005	EDEX	0.01MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020649-006	EDEX	0.02MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020649-007	EDEX	0.04MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020649-001	EDEX	0.005MG/VIAL	INJECTABLE / INJECTION			1997-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020649-002	EDEX	0.01MG/VIAL	INJECTABLE / INJECTION	AP	RLD	1997-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020649-003	EDEX	0.02MG/VIAL	INJECTABLE / INJECTION	AP	RLD	1997-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020649-004	EDEX	0.04MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020649-005	EDEX	0.01MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020649-006	EDEX	0.02MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020649-007	EDEX	0.04MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020649-001	EDEX	0.005MG/VIAL	INJECTABLE / INJECTION			1997-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020649-002	EDEX	0.01MG/VIAL	INJECTABLE / INJECTION	AP	RLD	1997-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020649-003	EDEX	0.02MG/VIAL	INJECTABLE / INJECTION	AP	RLD	1997-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020649-004	EDEX	0.04MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020649-005	EDEX	0.01MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020649-006	EDEX	0.02MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020649-007	EDEX	0.04MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020649-001	EDEX	0.005MG/VIAL	INJECTABLE / INJECTION			1997-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020649-002	EDEX	0.01MG/VIAL	INJECTABLE / INJECTION	AP	RLD	1997-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020649-003	EDEX	0.02MG/VIAL	INJECTABLE / INJECTION	AP	RLD	1997-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020649-004	EDEX	0.04MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020649-005	EDEX	0.01MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N020649-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020649-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020649-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020649-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020649-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020649-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020649-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020649-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020649-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020649-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020649-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020649-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020649-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020649-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020649-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020649-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020649-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020649-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020649-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020649-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020649-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020649-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020649-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020649-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020649-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020649-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020649-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020649-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020649-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020649-004	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020649-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020649-003	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020649-004	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020649-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020649-003	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020649-004	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020649-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020649-003	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020649-004	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020649-002	AP	1	`1e350fbaab3a…`

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
Edex	ALPROSTADIL	Endo USA, Inc.	e8b8ec8d-1318-43e4-a182-446e9f9579de	2024-03-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020649 application number: NDA020649 ndc (product): 52244-010 ndc (product): 52244-020 ndc (product): 52244-040

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52244-010	Edex	alprostadil	Endo Pharmaceuticals, Inc.	NDA	Current
52244-010	Edex	alprostadil	Endo Pharmaceuticals Inc.	NDA	Current
52244-020	Edex	alprostadil	Endo Pharmaceuticals, Inc.	NDA	Current
52244-020	Edex	alprostadil	Endo Pharmaceuticals Inc.	NDA	Current
52244-040	Edex	alprostadil	Endo Pharmaceuticals, Inc.	NDA	Current
52244-040	Edex	alprostadil	Endo Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
35077	SUPPL	2015-03-26
25444	SUPPL	2015-03-11
25443	SUPPL	2006-06-12
12922	SUPPL	2006-06-12
41522	ORIG	2003-08-08