Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Blenheim Pharmacal, Inc.
171434587
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Blenheim Pharmacal, Inc.
Blenheim Pharmacal, Inc.
Blenheim Pharmacal, Inc.
171434587
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Metoprolol Tartrate
Product Details
NDC Product Code
10544-263Application Number
ANDA074141Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 18, 2015HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
MetoprololActive
Code: W5S57Y3A5LClass: ACTIBQuantity: 50 mg in 1 1
D&C RED NO. 30Inactive
Code: 2S42T2808BClass: IACT