You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 2, 2024

Details for New Drug Application (NDA): 075945


✉ Email this page to a colleague

« Back to Dashboard


NDA 075945 describes AMNESTEEM, which is a drug marketed by Mylan Pharms Inc and is included in one NDA. It is available from one supplier. Additional details are available on the AMNESTEEM profile page.

The generic ingredient in AMNESTEEM is isotretinoin. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.
Summary for 075945
Tradename:AMNESTEEM
Applicant:Mylan Pharms Inc
Ingredient:isotretinoin
Patents:0
Pharmacology for NDA: 075945
Medical Subject Heading (MeSH) Categories for 075945
Suppliers and Packaging for NDA: 075945
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMNESTEEM isotretinoin CAPSULE;ORAL 075945 ANDA Mylan Pharmaceuticals Inc. 0378-6611 0378-6611-93 3 BLISTER PACK in 1 CARTON (0378-6611-93) / 10 CAPSULE in 1 BLISTER PACK (0378-6611-85)
AMNESTEEM isotretinoin CAPSULE;ORAL 075945 ANDA Mylan Pharmaceuticals Inc. 0378-6612 0378-6612-93 3 BLISTER PACK in 1 CARTON (0378-6612-93) / 10 CAPSULE in 1 BLISTER PACK (0378-6612-85)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Nov 8, 2002TE:AB1RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Nov 8, 2002TE:AB1RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength40MG
Approval Date:Nov 8, 2002TE:AB1RLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.