Application 087355

Type: ANDA
Sponsor: FOUGERA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NITROGLYCERIN	NITROGLYCERIN	OINTMENT;TRANSDERMAL	2%	No	Yes

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

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
A087355-001	NITROGLYCERIN	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL	AB	RLD, RS	1988-07-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A087355-001	AB

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 2 of 2 · 44 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
2022-10-28 04:53 UTC	2022-10	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RS	1988-07-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RS	1988-07-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RS	1988-07-08	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL	AB	RLD, RS	1988-07-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A087355-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A087355-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A087355-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A087355-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087355-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087355-001	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A087355-001	AB	1	`a50c72e98297…`

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
NITRO-BID	NITROGLYCERIN	Savage Laboratories a division of Fougera Pharmaceuticals, LLC	e464e9bb-48e8-4b9f-9fff-e220cfbac0c5	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087355 application number: ANDA087355 ndc (product): 0281-0326
NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co LLC, DBA HealthFirst	7da79fdf-0969-1ddd-e053-2991aa0a3ec4	2022-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087355 application number: ANDA087355 ndc (product): 51662-1340

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0168-0326	NITRO-BID	Nitroglycerin	E. FOUGERA & CO., A division of Nycomed US Inc.	ANDA	Current
0281-0326	NITRO-BID	Nitroglycerin	Savage Laboratories a division of Fougera Pharmaceuticals Inc.	ANDA	Current
0281-0326	NITRO-BID	Nitroglycerin	Savage Laboratories a division of Fougera Pharmaceuticals Inc.	ANDA	Current
0281-0326	NITRO-BID	Nitroglycerin	Savage Laboratories a div	ANDA	Current
0281-0326	NITRO-BID	Nitroglycerin	Savage Laboratories a division of Fougera Pharmaceuticals Inc.	ANDA	Current
0281-0326	NITRO-BID	Nitroglycerin	Savage Laboratories a division of Fougera Pharmaceuticals Inc.	ANDA	Current
51662-1340	NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1340	NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1340	NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1340	NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current