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FDA Approval

METOPROLOL TARTRATE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Youngtech Pharmaceuticals, Inc.
DUNS: 078622595
Effective Date
February 9, 2020
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Metoprolol(50 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Youngtech Pharmaceuticals, Inc.

078622595

Manufacturing Establishments2

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Yabao Pharmaceutical Co. Ltd.

Youngtech Pharmaceuticals, Inc.

Youngtech Pharmaceuticals, Inc.

421252976

Zhejiang Yongtai Pharmaceutical Co., Ltd.

Youngtech Pharmaceuticals, Inc.

Youngtech Pharmaceuticals, Inc.

544302778

Products3

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
69445-005
Application Number
ANDA208955
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 9, 2020
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MetoprololActive
Code: W5S57Y3A5LClass: ACTIBQuantity: 50 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6BClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT

METOPROLOL TARTRATE

Product Details

NDC Product Code
69445-006
Application Number
ANDA208955
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 9, 2020
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MetoprololActive
Code: W5S57Y3A5LClass: ACTIBQuantity: 100 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6BClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT

METOPROLOL TARTRATE

Product Details

NDC Product Code
69445-004
Application Number
ANDA208955
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 9, 2020
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MetoprololActive
Code: W5S57Y3A5LClass: ACTIBQuantity: 25 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6BClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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