Product Details for NDA 012787
SYNALAR (FLUOCINOLONE ACETONIDE)
0.01%
Marketing Status: Prescription
0.025%
Marketing Status: Prescription
0.025%
Marketing Status: Prescription
0.01%
Marketing Status: Prescription
Active Ingredient: FLUOCINOLONE ACETONIDE
Proprietary Name: SYNALAR
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 0.01%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AT
Application Number: N012787
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: MEDIMETRIKS PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
SYNALAR (FLUOCINOLONE ACETONIDE)
Proprietary Name: SYNALAR
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 0.01%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AT
Application Number: N012787
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: MEDIMETRIKS PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
0.025%
Marketing Status: Prescription
Active Ingredient: FLUOCINOLONE ACETONIDE
Proprietary Name: SYNALAR
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 0.025%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AT
Application Number: N012787
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: MEDIMETRIKS PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
SYNALAR (FLUOCINOLONE ACETONIDE)
Proprietary Name: SYNALAR
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 0.025%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AT
Application Number: N012787
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: MEDIMETRIKS PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
0.025%
Marketing Status: Prescription
Active Ingredient: FLUOCINOLONE ACETONIDE
Proprietary Name: SYNALAR
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 0.025%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AT
Application Number: N012787
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: MEDIMETRIKS PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: SYNALAR
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 0.025%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AT
Application Number: N012787
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: MEDIMETRIKS PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information