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.
ROPINIROLE
Product Details
NDC Product Code
72189-222Application Number
ANDA204022Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 22, 2021FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
RopiniroleActive
Code: D7ZD41RZI9Class: ACTIMQuantity: 1 mg in 1 1
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT