Application 090063

Type: ANDA
Sponsor: MYLAN PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVOFLOXACIN	LEVOFLOXACIN	TABLET; ORAL	250MG	No	No
002	LEVOFLOXACIN	LEVOFLOXACIN	TABLET; ORAL	500MG	No	No
003	LEVOFLOXACIN	LEVOFLOXACIN	TABLET; ORAL	750MG	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 4 · 79 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	b8ac5047-5203-42c4-886b-dd0b08a1786f	2026-01-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	16d51c1c-4144-4be7-9356-98fcee621ecd	2026-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Northwind Health Company, LLC	f2f090c2-3ee1-7689-e053-2995a90abe38	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Northwind Health Company, LLC	f780bb91-483a-d1a6-e053-6294a90ab74b	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Northwind Health Company, LLC	f33140d5-59ad-3379-e053-2995a90ae286	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	BPI LABS LLC	b6d9740b-2f9d-4f1c-bc9b-4c2150b22f10	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
levofloxacin	LEVOFLOXACIN	Redpharm Drug	301ecffc-ecaf-01de-e063-6294a90a61b3	2025-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	ST. MARY'S MEDICAL PARK PHARMACY	46a3c619-b2a3-3f28-e063-6394a90a2309	2025-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	NuCare Pharmaceuticals,Inc.	c6027cde-b9fe-e593-e053-2995a90ac2c1	2025-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Hospira, Inc	5a1534af-aa1c-4f1d-ba9f-9415b14e1af2	2025-11-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	VERITYRX, LLC	427a2077-5dbb-3c5e-e063-6294a90a0839	2025-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	PD-Rx Pharmaceuticals, Inc.	814450ae-439e-4a5d-8c60-9b21b6f14be5	2025-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	PD-Rx Pharmaceuticals, Inc.	b1a4aabb-42af-4133-8e82-0c7ec8fa79c3	2025-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	PD-Rx Pharmaceuticals, Inc.	b8defac4-9deb-433b-928e-0ef4ee0123a2	2025-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
levofloxacin	LEVOFLOXACIN	Bryant Ranch Prepack	cbd5153f-fada-4682-b858-dc3b6e3173cc	2025-09-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Lannett Company, Inc.	362fb864-3afb-4841-a7c4-b64b1346aba0	2025-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	A-S Medication Solutions	1538ec66-f385-401e-8cfb-d794691e7176	2025-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Proficient Rx LP	64141d0d-0347-470f-a427-9925a2eb357e	2025-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Redpharm Drug	0a0fd993-7bea-42d8-e063-6394a90a4e0e	2025-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
LEVOFLOXACIN	LEVOFLOXACIN	Advagen Pharma Limited	f2eb9444-333d-4b05-8cf3-2e6690a2bf99	2025-03-10	Warnings, Adverse reactions	Name fallback brand name: LEVOFLOXACIN generic name: LEVOFLOXACIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.