Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
DIRECT RX
079254320
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
DIRECT RX
DIRECT RX
DIRECT RX
079254320
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
MOXIFLOXACIN
Product Details
NDC Product Code
61919-553Application Number
ANDA090080Marketing Category
ANDA (C73584)Route of Administration
OPHTHALMICEffective Date
July 30, 2018SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
BORIC ACIDInactive
Code: R57ZHV85D4Class: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
Code: B8956S8609Class: ACTIBQuantity: 5 mg in 1 mL