Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 200480

Expand all

DYCLOPRO (DYCLONINE HYDROCHLORIDE)
0.5%
Marketing Status: Prescription

Active Ingredient: DYCLONINE HYDROCHLORIDE
Proprietary Name: DYCLOPRO
Dosage Form; Route of Administration: SOLUTION; TOPICAL
Strength: 0.5%
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A200480
Product Number: 001
Approval Date: Nov 20, 2018
Applicant Holder Full Name: SEPTODONT INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DYCLOPRO (DYCLONINE HYDROCHLORIDE)
1%
Marketing Status: Prescription

Active Ingredient: DYCLONINE HYDROCHLORIDE
Proprietary Name: DYCLOPRO
Dosage Form; Route of Administration: SOLUTION; TOPICAL
Strength: 1%
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A200480
Product Number: 002
Approval Date: Nov 20, 2018
Applicant Holder Full Name: SEPTODONT INC
Marketing Status:  Prescription
Patent and Exclusivity Information