Product Details for ANDA 206752
PREGABALIN (PREGABALIN)
25MG
Marketing Status: Discontinued
50MG
Marketing Status: Discontinued
75MG
Marketing Status: Discontinued
100MG
Marketing Status: Discontinued
150MG
Marketing Status: Discontinued
200MG
Marketing Status: Discontinued
225MG
Marketing Status: Discontinued
300MG
Marketing Status: Discontinued
25MG
Marketing Status: Discontinued
Active Ingredient: PREGABALIN
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A206752
Product Number: 001
Approval Date: Dec 9, 2022
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
PREGABALIN (PREGABALIN)
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A206752
Product Number: 001
Approval Date: Dec 9, 2022
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
50MG
Marketing Status: Discontinued
Active Ingredient: PREGABALIN
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A206752
Product Number: 002
Approval Date: Dec 9, 2022
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
PREGABALIN (PREGABALIN)
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A206752
Product Number: 002
Approval Date: Dec 9, 2022
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
75MG
Marketing Status: Discontinued
Active Ingredient: PREGABALIN
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 75MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A206752
Product Number: 003
Approval Date: Dec 9, 2022
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
PREGABALIN (PREGABALIN)
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 75MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A206752
Product Number: 003
Approval Date: Dec 9, 2022
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
100MG
Marketing Status: Discontinued
Active Ingredient: PREGABALIN
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A206752
Product Number: 004
Approval Date: Dec 9, 2022
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
PREGABALIN (PREGABALIN)
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A206752
Product Number: 004
Approval Date: Dec 9, 2022
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
150MG
Marketing Status: Discontinued
Active Ingredient: PREGABALIN
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 150MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A206752
Product Number: 005
Approval Date: Dec 9, 2022
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
PREGABALIN (PREGABALIN)
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 150MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A206752
Product Number: 005
Approval Date: Dec 9, 2022
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
200MG
Marketing Status: Discontinued
Active Ingredient: PREGABALIN
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A206752
Product Number: 006
Approval Date: Dec 9, 2022
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
PREGABALIN (PREGABALIN)
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A206752
Product Number: 006
Approval Date: Dec 9, 2022
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
225MG
Marketing Status: Discontinued
Active Ingredient: PREGABALIN
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 225MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A206752
Product Number: 007
Approval Date: Dec 9, 2022
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
PREGABALIN (PREGABALIN)
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 225MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A206752
Product Number: 007
Approval Date: Dec 9, 2022
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
300MG
Marketing Status: Discontinued
Active Ingredient: PREGABALIN
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A206752
Product Number: 008
Approval Date: Dec 9, 2022
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A206752
Product Number: 008
Approval Date: Dec 9, 2022
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information