Application 075073

Type: ANDA
Sponsor: MYLAN TECHNOLOGIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NITROGLYCERIN	NITROGLYCERIN	FILM, EXTENDED RELEASE; TRANSDERMAL	0.2MG/HR	No	No

Source provenance: Browse the complete Orange Book source catalog.

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 4 of 4 · 68 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co LLC, DBA HealthFirst	7da79fdf-0969-1ddd-e053-2991aa0a3ec4	2022-12-09	Warnings, Adverse reactions	Name fallback brand name: NITROGLYCERIN generic name: NITROGLYCERIN
nitroglycerin lingual	NITROGLYCERIN	Padagis Israel Pharmaceuticals Ltd	e7bbeff1-e4f1-43a6-a1b3-a8c3dcae817d	2022-09-01	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
Nitroglycerin	NITROGLYCERIN	Proficient Rx LP	67a15ee9-a6ae-4a60-8333-e06c608cfd71	2022-07-01	Warnings, Adverse reactions	Name fallback brand name: Nitroglycerin generic name: NITROGLYCERIN
Nitroglycerin	NITROGLYCERIN	American Regent, Inc.	8c52cdf6-87be-4719-b105-f08be096d462	2021-07-22	Warnings, Adverse reactions	Name fallback brand name: Nitroglycerin generic name: NITROGLYCERIN
Nitroglycerin Transdermal Infusion System	NITROGLYCERIN	Dr. Reddy's Laboratories, Inc.	4f85d2e0-2e37-fcd1-276d-5a6466554289	2020-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
Nitrostat	NITROGLYCERIN	Proficient Rx LP	6fe3965f-0dd8-4bae-9771-de25074cb1b0	2019-11-01	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
Nitroglycerin In Dextrose	NITROGLYCERIN	Baxter Healthcare Company	457a026c-ebce-4701-9deb-2d7652759a99	2016-08-22	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
Nitroglycerin	NITROGLYCERIN	Mylan Pharmaceuticals Inc.	e98a2692-1cb9-4994-98d8-1d8d9ef1a256	2014-11-03	Warnings, Adverse reactions	Name fallback brand name: Nitroglycerin generic name: NITROGLYCERIN

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
22412	ORIG	1999-11-12