Application 090405

Type: ANDA
Sponsor: ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LETROZOLE	LETROZOLE	TABLET; ORAL	2.5MG	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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Letrozole	LETROZOLE	NuCare Pharmaceuticals,Inc.	1b408ba8-05f7-1cf1-e063-6394a90a42bc	2024-06-19	Warnings, Adverse reactions	Name fallback brand name: Letrozole generic name: LETROZOLE
Letrozole	LETROZOLE	Proficient Rx LP	e1390a0d-0280-49a5-a2d4-d2e13e9952ca	2021-07-01	Warnings, Adverse reactions	Name fallback brand name: Letrozole generic name: LETROZOLE
Letrozole	LETROZOLE	Natco Pharma Limited	35c73219-c39e-4e10-b944-76009b061e79	2020-11-05	Warnings, Adverse reactions	Name fallback brand name: Letrozole generic name: LETROZOLE
Letrozole	LETROZOLE	Dr. Reddy's Laboratories Limited	6cfd29d7-f519-7b8c-4814-07b39f367f0d	2018-12-06	Warnings, Adverse reactions	Name fallback brand name: Letrozole generic name: LETROZOLE

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65841-744	letrozole	letrozole	Cadila Healthcare Limited	ANDA	Current
68382-363	letrozole	letrozole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current