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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 078584


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NDA 078584 describes NEVIRAPINE, which is a drug marketed by Aurobindo, Cipla, Alvogen, Apotex, Aurobindo Pharma, Macleods Pharms Ltd, Mylan, Sandoz, Tech Organized, Apotex Inc, Hetero Labs Ltd Iii, Micro Labs Ltd, Mylan Labs, Mylan Pharms Inc, Prinston Inc, and Strides Pharma, and is included in twenty-three NDAs. It is available from seven suppliers. Additional details are available on the NEVIRAPINE profile page.

The generic ingredient in NEVIRAPINE is nevirapine. There are twenty drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the nevirapine profile page.
Summary for 078584
Tradename:NEVIRAPINE
Applicant:Hetero Labs Ltd Iii
Ingredient:nevirapine
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 078584
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEVIRAPINE nevirapine TABLET;ORAL 078584 ANDA Camber Pharmaceuticals, Inc. 31722-505 31722-505-01 100 TABLET in 1 BOTTLE (31722-505-01)
NEVIRAPINE nevirapine TABLET;ORAL 078584 ANDA Camber Pharmaceuticals, Inc. 31722-505 31722-505-05 500 TABLET in 1 BOTTLE (31722-505-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:May 22, 2012TE:ABRLD:No

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