Details for New Drug Application (NDA): 020438
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NDA 020438 describes VESANOID, which is a drug marketed by Cheplapharm and is included in one NDA. It is available from one supplier. Additional details are available on the VESANOID profile page.
The generic ingredient in VESANOID 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.
The generic ingredient in VESANOID 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 020438
| Tradename: | VESANOID |
| Applicant: | Cheplapharm |
| Ingredient: | tretinoin |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 020438
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VESANOID | tretinoin | CAPSULE;ORAL | 020438 | NDA | H2-Pharma, LLC | 61269-750 | 61269-750-10 | 100 CAPSULE in 1 BOTTLE, PLASTIC (61269-750-10) |
| VESANOID | tretinoin | CAPSULE;ORAL | 020438 | NDA AUTHORIZED GENERIC | H2-Pharma, LLC | 61269-850 | 61269-850-10 | 100 CAPSULE in 1 BOTTLE, PLASTIC (61269-850-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 22, 1995 | TE: | RLD: | Yes | |||||
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