Adalat CC
ADALATCC ( nifedipine ) Extended Release Tablets For Oral Use
Approved
Approval ID
8d247bfb-8309-4cb8-847c-b4619a3d36d8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 14, 2014
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
nifedipine
PRODUCT DETAILS
NDC Product Code67544-185
Application NumberNDA020198
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateMay 14, 2014
Generic Namenifedipine
INGREDIENTS (12)
NIFEDIPINEActive
Quantity: 90 mg in 1 1
Code: I9ZF7L6G2L
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT