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Generated: November 20, 2017

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Details for New Drug Application (NDA): 202033

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NDA 202033 describes METOPROLOL SUCCINATE, which is a drug marketed by Wockhardt, Dr Reddys Labs Ltd, Actavis Labs Fl Inc, Mylan Pharms Inc, Nesher Pharms, Actavis Elizabeth, Sandoz, and Reddys, and is included in twelve NDAs. It is available from thirty-six suppliers. Additional details are available on the METOPROLOL SUCCINATE profile page.

The generic ingredient in METOPROLOL SUCCINATE is metoprolol succinate. There are fifty-eight drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the metoprolol succinate profile page.

Summary for 202033

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 202033

Mechanism of ActionAdrenergic beta-Antagonists

Suppliers and Packaging for NDA: 202033

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOPROLOL SUCCINATE
metoprolol succinate
TABLET, EXTENDED RELEASE;ORAL 202033 ANDA Mylan Institutional Inc. 51079-169 51079-169-20 100 BLISTER PACK in 1 CARTON (51079-169-20) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (51079-169-01)
METOPROLOL SUCCINATE
metoprolol succinate
TABLET, EXTENDED RELEASE;ORAL 202033 ANDA Mylan Institutional Inc. 51079-170 51079-170-20 100 BLISTER PACK in 1 CARTON (51079-170-20) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (51079-170-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 25MG TARTRATE
Approval Date:Dec 15, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 50MG TARTRATE
Approval Date:Dec 15, 2011TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 100MG TARTRATE
Approval Date:Dec 15, 2011TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Accenture
US Army
Express Scripts
Julphar
Boehringer Ingelheim
Citi
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Daiichi Sankyo
Medtronic

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