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Generated: November 17, 2018

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Details for New Drug Application (NDA): 202099

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NDA 202099 describes ZENATANE, which is a drug marketed by Dr Reddys Labs Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the ZENATANE profile page.

The generic ingredient in ZENATANE is isotretinoin. There are thirteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.
Summary for 202099
Tradename:ZENATANE
Applicant:Dr Reddys Labs Ltd
Ingredient:isotretinoin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202099
Ingredient-typeRetinoids
Medical Subject Heading (MeSH) Categories for 202099
Suppliers and Packaging for NDA: 202099
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZENATANE isotretinoin CAPSULE;ORAL 202099 ANDA Dr. Reddy's Laboratories Limited 55111-113 55111-113-78 10 BLISTER PACK in 1 CARTON (55111-113-78) > 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-113-79)
ZENATANE isotretinoin CAPSULE;ORAL 202099 ANDA Dr. Reddy's Laboratories Limited 55111-113 55111-113-81 3 BLISTER PACK in 1 CARTON (55111-113-81) > 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-113-79)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Mar 25, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Mar 25, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength40MG
Approval Date:Mar 25, 2013TE:ABRLD:No

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