Product Details for ANDA 206329
FENTANYL CITRATE (FENTANYL CITRATE)
EQ 0.1MG BASE
Marketing Status: Discontinued
EQ 0.2MG BASE
Marketing Status: Discontinued
EQ 0.3MG BASE
Marketing Status: Discontinued
EQ 0.4MG BASE
Marketing Status: Discontinued
EQ 0.6MG BASE
Marketing Status: Discontinued
EQ 0.8MG BASE
Marketing Status: Discontinued
EQ 0.1MG BASE
Marketing Status: Discontinued
Active Ingredient: FENTANYL CITRATE
Proprietary Name: FENTANYL CITRATE
Dosage Form; Route of Administration: TABLET; BUCCAL, SUBLINGUAL
Strength: EQ 0.1MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A206329
Product Number: 001
Approval Date: Aug 22, 2022
Applicant Holder Full Name: DR REDDYS LABORATORIES SA
Marketing Status: Discontinued
Patent and Exclusivity Information
FENTANYL CITRATE (FENTANYL CITRATE)
Proprietary Name: FENTANYL CITRATE
Dosage Form; Route of Administration: TABLET; BUCCAL, SUBLINGUAL
Strength: EQ 0.1MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A206329
Product Number: 001
Approval Date: Aug 22, 2022
Applicant Holder Full Name: DR REDDYS LABORATORIES SA
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 0.2MG BASE
Marketing Status: Discontinued
Active Ingredient: FENTANYL CITRATE
Proprietary Name: FENTANYL CITRATE
Dosage Form; Route of Administration: TABLET; BUCCAL, SUBLINGUAL
Strength: EQ 0.2MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A206329
Product Number: 002
Approval Date: Aug 22, 2022
Applicant Holder Full Name: DR REDDYS LABORATORIES SA
Marketing Status: Discontinued
Patent and Exclusivity Information
FENTANYL CITRATE (FENTANYL CITRATE)
Proprietary Name: FENTANYL CITRATE
Dosage Form; Route of Administration: TABLET; BUCCAL, SUBLINGUAL
Strength: EQ 0.2MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A206329
Product Number: 002
Approval Date: Aug 22, 2022
Applicant Holder Full Name: DR REDDYS LABORATORIES SA
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 0.3MG BASE
Marketing Status: Discontinued
Active Ingredient: FENTANYL CITRATE
Proprietary Name: FENTANYL CITRATE
Dosage Form; Route of Administration: TABLET; BUCCAL, SUBLINGUAL
Strength: EQ 0.3MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A206329
Product Number: 003
Approval Date: Aug 22, 2022
Applicant Holder Full Name: DR REDDYS LABORATORIES SA
Marketing Status: Discontinued
Patent and Exclusivity Information
FENTANYL CITRATE (FENTANYL CITRATE)
Proprietary Name: FENTANYL CITRATE
Dosage Form; Route of Administration: TABLET; BUCCAL, SUBLINGUAL
Strength: EQ 0.3MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A206329
Product Number: 003
Approval Date: Aug 22, 2022
Applicant Holder Full Name: DR REDDYS LABORATORIES SA
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 0.4MG BASE
Marketing Status: Discontinued
Active Ingredient: FENTANYL CITRATE
Proprietary Name: FENTANYL CITRATE
Dosage Form; Route of Administration: TABLET; BUCCAL, SUBLINGUAL
Strength: EQ 0.4MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A206329
Product Number: 004
Approval Date: Aug 22, 2022
Applicant Holder Full Name: DR REDDYS LABORATORIES SA
Marketing Status: Discontinued
Patent and Exclusivity Information
FENTANYL CITRATE (FENTANYL CITRATE)
Proprietary Name: FENTANYL CITRATE
Dosage Form; Route of Administration: TABLET; BUCCAL, SUBLINGUAL
Strength: EQ 0.4MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A206329
Product Number: 004
Approval Date: Aug 22, 2022
Applicant Holder Full Name: DR REDDYS LABORATORIES SA
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 0.6MG BASE
Marketing Status: Discontinued
Active Ingredient: FENTANYL CITRATE
Proprietary Name: FENTANYL CITRATE
Dosage Form; Route of Administration: TABLET; BUCCAL, SUBLINGUAL
Strength: EQ 0.6MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A206329
Product Number: 005
Approval Date: Aug 22, 2022
Applicant Holder Full Name: DR REDDYS LABORATORIES SA
Marketing Status: Discontinued
Patent and Exclusivity Information
FENTANYL CITRATE (FENTANYL CITRATE)
Proprietary Name: FENTANYL CITRATE
Dosage Form; Route of Administration: TABLET; BUCCAL, SUBLINGUAL
Strength: EQ 0.6MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A206329
Product Number: 005
Approval Date: Aug 22, 2022
Applicant Holder Full Name: DR REDDYS LABORATORIES SA
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 0.8MG BASE
Marketing Status: Discontinued
Active Ingredient: FENTANYL CITRATE
Proprietary Name: FENTANYL CITRATE
Dosage Form; Route of Administration: TABLET; BUCCAL, SUBLINGUAL
Strength: EQ 0.8MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A206329
Product Number: 006
Approval Date: Aug 22, 2022
Applicant Holder Full Name: DR REDDYS LABORATORIES SA
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: FENTANYL CITRATE
Dosage Form; Route of Administration: TABLET; BUCCAL, SUBLINGUAL
Strength: EQ 0.8MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A206329
Product Number: 006
Approval Date: Aug 22, 2022
Applicant Holder Full Name: DR REDDYS LABORATORIES SA
Marketing Status: Discontinued
Patent and Exclusivity Information