Product Details for ANDA 040712
PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE)
12.5MG
Marketing Status: Prescription
25MG
Marketing Status: Prescription
50MG
Marketing Status: Prescription
12.5MG
Marketing Status: Prescription
Active Ingredient: PROMETHAZINE HYDROCHLORIDE
Proprietary Name: PROMETHAZINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A040712
Product Number: 002
Approval Date: May 4, 2007
Applicant Holder Full Name: KVK TECH INC
Marketing Status: Prescription
Patent and Exclusivity Information
PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE)
Proprietary Name: PROMETHAZINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A040712
Product Number: 002
Approval Date: May 4, 2007
Applicant Holder Full Name: KVK TECH INC
Marketing Status: Prescription
Patent and Exclusivity Information
25MG
Marketing Status: Prescription
Active Ingredient: PROMETHAZINE HYDROCHLORIDE
Proprietary Name: PROMETHAZINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A040712
Product Number: 001
Approval Date: Jul 31, 2006
Applicant Holder Full Name: KVK TECH INC
Marketing Status: Prescription
Patent and Exclusivity Information
PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE)
Proprietary Name: PROMETHAZINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A040712
Product Number: 001
Approval Date: Jul 31, 2006
Applicant Holder Full Name: KVK TECH INC
Marketing Status: Prescription
Patent and Exclusivity Information
50MG
Marketing Status: Prescription
Active Ingredient: PROMETHAZINE HYDROCHLORIDE
Proprietary Name: PROMETHAZINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A040712
Product Number: 003
Approval Date: Jul 31, 2006
Applicant Holder Full Name: KVK TECH INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: PROMETHAZINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A040712
Product Number: 003
Approval Date: Jul 31, 2006
Applicant Holder Full Name: KVK TECH INC
Marketing Status: Prescription
Patent and Exclusivity Information