Details for New Drug Application (NDA): 214902
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The generic ingredient in TWYNEO is benzoyl peroxide; tretinoin. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the benzoyl peroxide; tretinoin profile page.
Summary for 214902
Tradename: | TWYNEO |
Applicant: | Galderma Labs Lp |
Ingredient: | benzoyl peroxide; tretinoin |
Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214902
Generic Entry Date for 214902*:
Constraining patent/regulatory exclusivity:
Dosage:
CREAM;TOPICAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 214902
Suppliers and Packaging for NDA: 214902
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TWYNEO | benzoyl peroxide; tretinoin | CREAM;TOPICAL | 214902 | NDA | Galderma Laboratories, L.P. | 0299-5945 | 0299-5945-00 | 6 g in 1 TUBE (0299-5945-00) |
TWYNEO | benzoyl peroxide; tretinoin | CREAM;TOPICAL | 214902 | NDA | Galderma Laboratories, L.P. | 0299-5945 | 0299-5945-05 | 30 g in 1 BOTTLE, PUMP (0299-5945-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 3%;0.1% | ||||
Approval Date: | Jul 26, 2021 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Jul 26, 2024 | ||||||||
Regulatory Exclusivity Use: | NEW COMBINATION | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jul 12, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TOPICAL TREATMENT OF ACNE VULGARIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 30, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TOPICAL TREATMENT OF ACNE VULGARIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER |
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