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Details for New Drug Application (NDA): 020184

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NDA 020184 describes ACEON, which is a drug marketed by Symplmed Pharms Llc and is included in one NDA. It is available from four suppliers. Additional details are available on the ACEON profile page.

The generic ingredient in ACEON is perindopril erbumine. There are fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the perindopril erbumine profile page.

Summary for NDA: 020184

Tradename:
ACEON
Applicant:
Symplmed Pharms Llc
Ingredient:
perindopril erbumine
Patents:0
Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 020184

Suppliers and Packaging for NDA: 020184

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACEON
perindopril erbumine
TABLET;ORAL 020184 NDA Lannett Company, Inc. 0527-1919 0527-1919-01 100 TABLET in 1 BOTTLE (0527-1919-01)
ACEON
perindopril erbumine
TABLET;ORAL 020184 NDA Lannett Company, Inc. 0527-1920 0527-1920-01 100 TABLET in 1 BOTTLE (0527-1920-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Dec 30, 1993TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Dec 30, 1993TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength8MG
Approval Date:Dec 30, 1993TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 020184

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Symplmed Pharms Llc
ACEON
perindopril erbumine
TABLET;ORAL020184-001Dec 30, 19934,508,729► subscribe
Symplmed Pharms Llc
ACEON
perindopril erbumine
TABLET;ORAL020184-003Dec 30, 19934,508,729► subscribe
Symplmed Pharms Llc
ACEON
perindopril erbumine
TABLET;ORAL020184-002Dec 30, 19935,162,362► subscribe
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