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Generated: June 26, 2019

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Details for New Drug Application (NDA): 200630

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NDA 200630 describes TADALAFIL, which is a drug marketed by Accord Hlthcare, Ajanta Pharma Ltd, Alembic Pharms Ltd, Amneal Pharms Co, Aurobindo Pharma Ltd, Cipla, Dr Reddys Labs Ltd, Hetero Labs Ltd Iii, Lupin Ltd, Mylan, Qilu Pharm Co Ltd, Sun Pharm, Sunshine Lake, Teva Pharms Usa, Torrent, Unichem Labs Ltd, Watson Labs Inc, and Zydus Pharms, and is included in twenty-seven NDAs. It is available from twenty-nine suppliers. Additional details are available on the TADALAFIL profile page.

The generic ingredient in TADALAFIL is tadalafil. There are twenty-five drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the tadalafil profile page.
Summary for 200630
Tradename:TADALAFIL
Applicant:Mylan
Ingredient:tadalafil
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 200630
Medical Subject Heading (MeSH) Categories for 200630
Suppliers and Packaging for NDA: 200630
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TADALAFIL tadalafil TABLET;ORAL 200630 ANDA Mylan Pharmaceuticals Inc. 0378-6976 0378-6976-91 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6976-91)
TADALAFIL tadalafil TABLET;ORAL 200630 ANDA Mylan Pharmaceuticals Inc. 0378-6976 0378-6976-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6976-93)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Aug 3, 2018TE:AB2RLD:No
Regulatory Exclusivity Expiration:Feb 5, 2019
Regulatory Exclusivity Use:PATENT CHALLENGE

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