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Details for New Drug Application (NDA): 200671

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NDA 200671 describes DURLAZA, which is a drug marketed by New Haven Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the DURLAZA profile page.

The generic ingredient in DURLAZA is aspirin. There are twenty-one drug master file entries for this compound. One supplier is listed for this compound. There is one tentative approval for this compound. Additional details are available on the aspirin profile page.

Summary for NDA: 200671

New Haven Pharms

Pharmacology for NDA: 200671

Suppliers and Packaging for NDA: 200671

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE, EXTENDED RELEASE;ORAL 200671 NDA New Haven Pharmaceuticals, Inc. 58487-001 58487-001-01 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (58487-001-01)
CAPSULE, EXTENDED RELEASE;ORAL 200671 NDA New Haven Pharmaceuticals, Inc. 58487-001 58487-001-02 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (58487-001-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength162.5MG
Approval Date:Sep 4, 2015TE:RLD:Yes

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