Product Details for ANDA 065217
CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE)
EQ 75MG BASE
Marketing Status: Prescription
EQ 150MG BASE
Marketing Status: Prescription
EQ 300MG BASE
Marketing Status: Prescription
EQ 75MG BASE
Marketing Status: Prescription
Active Ingredient: CLINDAMYCIN HYDROCHLORIDE
Proprietary Name: CLINDAMYCIN HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 75MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A065217
Product Number: 001
Approval Date: Jan 31, 2005
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE)
Proprietary Name: CLINDAMYCIN HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 75MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A065217
Product Number: 001
Approval Date: Jan 31, 2005
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 150MG BASE
Marketing Status: Prescription
Active Ingredient: CLINDAMYCIN HYDROCHLORIDE
Proprietary Name: CLINDAMYCIN HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A065217
Product Number: 002
Approval Date: Jan 31, 2005
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE)
Proprietary Name: CLINDAMYCIN HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A065217
Product Number: 002
Approval Date: Jan 31, 2005
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 300MG BASE
Marketing Status: Prescription
Active Ingredient: CLINDAMYCIN HYDROCHLORIDE
Proprietary Name: CLINDAMYCIN HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 300MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A065217
Product Number: 003
Approval Date: Jan 31, 2005
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: CLINDAMYCIN HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 300MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A065217
Product Number: 003
Approval Date: Jan 31, 2005
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information