Product Details for NDA 021446
LYRICA (PREGABALIN)
25MG
Marketing Status: Prescription
50MG
Marketing Status: Prescription
75MG
Marketing Status: Prescription
100MG
Marketing Status: Prescription
150MG
Marketing Status: Prescription
200MG
Marketing Status: Prescription
225MG
Marketing Status: Prescription
300MG
Marketing Status: Prescription
25MG
Marketing Status: Prescription
Active Ingredient: PREGABALIN
Proprietary Name: LYRICA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021446
Product Number: 001
Approval Date: Dec 30, 2004
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status: Prescription
Patent and Exclusivity Information
LYRICA (PREGABALIN)
Proprietary Name: LYRICA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021446
Product Number: 001
Approval Date: Dec 30, 2004
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status: Prescription
Patent and Exclusivity Information
50MG
Marketing Status: Prescription
Active Ingredient: PREGABALIN
Proprietary Name: LYRICA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021446
Product Number: 002
Approval Date: Dec 30, 2004
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status: Prescription
Patent and Exclusivity Information
LYRICA (PREGABALIN)
Proprietary Name: LYRICA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021446
Product Number: 002
Approval Date: Dec 30, 2004
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status: Prescription
Patent and Exclusivity Information
75MG
Marketing Status: Prescription
Active Ingredient: PREGABALIN
Proprietary Name: LYRICA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 75MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021446
Product Number: 003
Approval Date: Dec 30, 2004
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status: Prescription
Patent and Exclusivity Information
LYRICA (PREGABALIN)
Proprietary Name: LYRICA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 75MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021446
Product Number: 003
Approval Date: Dec 30, 2004
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status: Prescription
Patent and Exclusivity Information
100MG
Marketing Status: Prescription
Active Ingredient: PREGABALIN
Proprietary Name: LYRICA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021446
Product Number: 004
Approval Date: Dec 30, 2004
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status: Prescription
Patent and Exclusivity Information
LYRICA (PREGABALIN)
Proprietary Name: LYRICA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021446
Product Number: 004
Approval Date: Dec 30, 2004
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status: Prescription
Patent and Exclusivity Information
150MG
Marketing Status: Prescription
Active Ingredient: PREGABALIN
Proprietary Name: LYRICA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 150MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021446
Product Number: 005
Approval Date: Dec 30, 2004
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status: Prescription
Patent and Exclusivity Information
LYRICA (PREGABALIN)
Proprietary Name: LYRICA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 150MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021446
Product Number: 005
Approval Date: Dec 30, 2004
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status: Prescription
Patent and Exclusivity Information
200MG
Marketing Status: Prescription
Active Ingredient: PREGABALIN
Proprietary Name: LYRICA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021446
Product Number: 006
Approval Date: Dec 30, 2004
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status: Prescription
Patent and Exclusivity Information
LYRICA (PREGABALIN)
Proprietary Name: LYRICA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021446
Product Number: 006
Approval Date: Dec 30, 2004
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status: Prescription
Patent and Exclusivity Information
225MG
Marketing Status: Prescription
Active Ingredient: PREGABALIN
Proprietary Name: LYRICA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 225MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021446
Product Number: 007
Approval Date: Dec 30, 2004
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status: Prescription
Patent and Exclusivity Information
LYRICA (PREGABALIN)
Proprietary Name: LYRICA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 225MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021446
Product Number: 007
Approval Date: Dec 30, 2004
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status: Prescription
Patent and Exclusivity Information
300MG
Marketing Status: Prescription
Active Ingredient: PREGABALIN
Proprietary Name: LYRICA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021446
Product Number: 008
Approval Date: Dec 30, 2004
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: LYRICA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021446
Product Number: 008
Approval Date: Dec 30, 2004
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status: Prescription
Patent and Exclusivity Information