Details for New Drug Application (NDA): 207955
✉ Email this page to a colleague
The generic ingredient in TRETINOIN is tretinoin. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the tretinoin profile page.
Summary for 207955
Tradename: | TRETINOIN |
Applicant: | Mylan |
Ingredient: | tretinoin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 207955
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TRETINOIN | tretinoin | GEL;TOPICAL | 207955 | ANDA | Mylan Pharmaceuticals Inc. | 0378-8090 | 0378-8090-45 | 1 TUBE in 1 CARTON (0378-8090-45) / 45 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 0.05% | ||||
Approval Date: | Aug 13, 2015 | TE: | AB | RLD: | No |
Complete Access Available with Subscription