Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Carilion Materials Management
079239644
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Carilion Materials Management
Carilion Materials Management
Carilion Materials Management
079239644
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Demeclocycline Hydrochloride
Product Details
NDC Product Code
68151-0155Application Number
ANDA065425Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
April 1, 2010POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1AClass: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
DemeclocyclineActive
Code: 29O079NTYTClass: ACTIBQuantity: 150 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
ALGINIC ACIDInactive
Code: 8C3Z4148WZClass: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4BClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6KClass: IACT