FDA Orange Book · active-ingredient family
Mequinol; tretinoin
Mequinol; tretinoin: 1 brand, 0 generics; first approved Dec 10, 1999.
Brand onlyHas discontinued products
Generic status & protection
No listed patents or exclusivity: brand product(s) only.
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
0
Presentations
1
Brand (NDA) products
Originator applications
- ALMIRALLNDA 0209221999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2%;0.01% SOLUTION TOPICAL Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
27 yr ago
Most recent approval
27 yr ago
All 1 application were approved in 1999.
Brand (NDA) 1100%
Generic (ANDA) 00%
Mequinol; tretinoin: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
