Details for New Drug Application (NDA): 215609
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NDA 215609 describes TRETINOIN MICROSPHERE, which is a drug marketed by Encube and is included in one NDA. It is available from two suppliers. Additional details are available on the TRETINOIN MICROSPHERE profile page.
The generic ingredient in TRETINOIN MICROSPHERE 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 TRETINOIN MICROSPHERE 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 215609
| Tradename: | TRETINOIN MICROSPHERE |
| Applicant: | Encube |
| Ingredient: | tretinoin |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 215609
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRETINOIN MICROSPHERE | tretinoin | GEL;TOPICAL | 215609 | ANDA | Encube Ethicals Private Limited | 21922-043 | 21922-043-40 | 1 BOTTLE, PUMP in 1 CARTON (21922-043-40) / 50 g in 1 BOTTLE, PUMP |
| TRETINOIN MICROSPHERE | tretinoin | GEL;TOPICAL | 215609 | ANDA | Bryant Ranch Prepack | 72162-2303 | 72162-2303-2 | 1 BOTTLE, PUMP in 1 CARTON (72162-2303-2) / 50 g in 1 BOTTLE, PUMP |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 0.08% | ||||
| Approval Date: | Aug 22, 2023 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Mar 6, 2024 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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