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Details for New Drug Application (NDA): 076498

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NDA 076498 describes TRETINOIN, which is a drug marketed by Allergan Sales Llc, Perrigo Pharma Intl, Spear Pharms Inc, Wockhardt, Teva Pharms, Barr Labs Inc, Anchen Pharms, and Suneva Medcl, and is included in fifteen NDAs. It is available from fifteen suppliers. Additional details are available on the TRETINOIN profile page.

The generic ingredient in TRETINOIN is tretinoin. There are twenty-four drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the tretinoin profile page.

Summary for NDA: 076498

Suneva Medcl
Therapeutic Class:Antineoplastics
Dermatological Agents

Pharmacology for NDA: 076498


Suppliers and Packaging for NDA: 076498

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CREAM;TOPICAL 076498 ANDA Suneva Medical, Inc. 50224-002 50224-002-04 60 g in 1 TUBE (50224-002-04)
CREAM;TOPICAL 076498 ANDA Suneva Medical, Inc. 50224-002 50224-002-05 40 g in 1 TUBE (50224-002-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.05%
Approval Date:Sep 15, 2005TE:AB2RLD:No

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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 verifification 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.