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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 091168


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NDA 091168 describes EMTRICITABINE, which is a drug marketed by Aurobindo Pharma Ltd, Cipla, Hetero Labs Ltd Iii, Amneal Pharms Co, Apotex, Aurobindo Pharma, Laurus, Lupin Ltd, Macleods Pharms Ltd, Mylan, Strides Pharma, Teva Pharms Usa, and Zydus Pharms, and is included in fifteen NDAs. It is available from three suppliers. Additional details are available on the EMTRICITABINE profile page.

The generic ingredient in EMTRICITABINE is emtricitabine; tenofovir disoproxil fumarate. There are eighteen drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the emtricitabine; tenofovir disoproxil fumarate profile page.
Summary for 091168
Tradename:EMTRICITABINE
Applicant:Cipla
Ingredient:emtricitabine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 091168
Medical Subject Heading (MeSH) Categories for 091168
Suppliers and Packaging for NDA: 091168
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EMTRICITABINE emtricitabine CAPSULE;ORAL 091168 ANDA Cipla USA Inc. 69097-642 69097-642-02 30 CAPSULE in 1 BOTTLE (69097-642-02)
EMTRICITABINE emtricitabine CAPSULE;ORAL 091168 ANDA Cipla USA Inc. 69097-642 69097-642-15 1000 CAPSULE in 1 BOTTLE (69097-642-15)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Jul 2, 2018TE:ABRLD:No

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