Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019452

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DERMA-SMOOTHE/FS (FLUOCINOLONE ACETONIDE)
0.01%
Marketing Status: Prescription

Active Ingredient: FLUOCINOLONE ACETONIDE
Proprietary Name: DERMA-SMOOTHE/FS
Dosage Form; Route of Administration: OIL; TOPICAL
Strength: 0.01%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AT
Application Number: N019452
Product Number: 001
Approval Date: Feb 3, 1988
Applicant Holder Full Name: HILL DERMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DERMA-SMOOTHE/FS (FLUOCINOLONE ACETONIDE)
0.01%
Marketing Status: Prescription

Active Ingredient: FLUOCINOLONE ACETONIDE
Proprietary Name: DERMA-SMOOTHE/FS
Dosage Form; Route of Administration: OIL; TOPICAL
Strength: 0.01%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AT
Application Number: N019452
Product Number: 002
Approval Date: Nov 9, 2005
Applicant Holder Full Name: HILL DERMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DERMOTIC (FLUOCINOLONE ACETONIDE)
0.01%
Marketing Status: Prescription

Active Ingredient: FLUOCINOLONE ACETONIDE
Proprietary Name: DERMOTIC
Dosage Form; Route of Administration: OIL/DROPS; OTIC
Strength: 0.01%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AT
Application Number: N019452
Product Number: 003
Approval Date: Nov 9, 2005
Applicant Holder Full Name: HILL DERMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information