Product Details for ANDA 074910
DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
60MG
Marketing Status: Prescription
90MG
Marketing Status: Prescription
120MG
Marketing Status: Prescription
60MG
Marketing Status: Prescription
Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 60MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A074910
Product Number: 001
Approval Date: May 2, 1997
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 60MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A074910
Product Number: 001
Approval Date: May 2, 1997
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
90MG
Marketing Status: Prescription
Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 90MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A074910
Product Number: 002
Approval Date: May 2, 1997
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 90MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A074910
Product Number: 002
Approval Date: May 2, 1997
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
120MG
Marketing Status: Prescription
Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 120MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB1
Application Number: A074910
Product Number: 003
Approval Date: May 2, 1997
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 120MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB1
Application Number: A074910
Product Number: 003
Approval Date: May 2, 1997
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information