Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
PSS World Medical Inc.
101822682
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
STAT Rx USA LLC
STAT Rx USA LLC
PSS World Medical Inc.
786036330
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ORPHENADRINE CITRATE
Product Details
NDC Product Code
42549-559Application Number
ANDA040368Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 1, 2012OrphenadrineActive
Code: X0A40N8I4SClass: ACTIBQuantity: 100 mg in 1 1
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4BClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT