Application 020451

Type: NDA
Sponsor: PINNACLE BIOLGS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PHOTOFRIN	PORFIMER SODIUM	INJECTABLE;INJECTION	75MG/VIAL	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
N020451-001	PHOTOFRIN	PORFIMER SODIUM	75MG/VIAL	INJECTABLE / INJECTION			1995-12-27

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020451-001	PHOTOFRIN	75MG/VIAL	INJECTABLE / INJECTION	1995-12-27	`e64feba35796…`

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
Photofrin	PORFIMER SODIUM	Pinnacle Biologics, Inc.	5c4841b4-fbc0-4163-8ee1-cb28629cbfbf	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020451 application number: NDA020451 ndc (product): 76128-155

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
76128-155	Photofrin	Porfimer Sodium	Pinnacle Biologics, Inc.	NDA	Current
76128-155	Photofrin	Porfimer Sodium	Pinnacle Biologics, Inc.	NDA	Current
76128-155	Photofrin	Porfimer Sodium	Pinnacle Biologics, Inc.	NDA	Current
76128-155	Photofrin	Porfimer Sodium	Pinnacle Biologics, Inc.	NDA	Current
76128-155	Photofrin	Porfimer Sodium	Pinnacle Biologics, Inc.	NDA	Current
76128-155	Photofrin	Porfimer Sodium	Pinnacle Biologics, Inc.	NDA	Current
76128-155	Photofrin	Porfimer Sodium	Pinnacle Biologics, Inc.	NDA	Current
76128-155	Photofrin	Porfimer Sodium	Pinnacle Biologics, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61516	SUPPL	2020-01-06
61491	SUPPL	2020-01-02
57647	ORIG	2019-02-15
24992	SUPPL	2011-07-05
34675	SUPPL	2011-06-28
2561	SUPPL	2011-04-06
12603	SUPPL	2011-04-04
34674	SUPPL	2008-09-09
2560	SUPPL	2008-09-09
41377	SUPPL	2006-07-25
2559	SUPPL	2005-10-20
24991	SUPPL	2003-08-15
12602	SUPPL	2003-08-14
2558	SUPPL	1998-12-22
2557	SUPPL	1998-01-09