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Details for New Drug Application (NDA): 071081

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NDA 071081 describes MECLOFENAMATE SODIUM, which is a drug marketed by Watson Labs, Usl Pharma, Barr, Vitarine, Am Therap, Sandoz, Par Pharm, and Mylan, and is included in nineteen NDAs. It is available from one supplier. Additional details are available on the MECLOFENAMATE SODIUM profile page.

The generic ingredient in MECLOFENAMATE SODIUM is meclofenamate sodium. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the meclofenamate sodium profile page.

Summary for NDA: 071081

meclofenamate sodium
Therapeutic Class:Analgesics
Anti-inflammatory Agents

Suppliers and Packaging for NDA: 071081

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
meclofenamate sodium
CAPSULE;ORAL 071081 ANDA Mylan Pharmaceuticals Inc. 0378-2150 0378-2150-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-2150-01)
meclofenamate sodium
CAPSULE;ORAL 071081 ANDA Mylan Pharmaceuticals Inc. 0378-3000 0378-3000-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3000-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Sep 3, 1986TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:Sep 3, 1986TE:RLD:No

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