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 1.

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.

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
2026-08-01 22:54:32	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
2026-08-01 22:54:32	2026-06	A087355-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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