Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 078469

Expand all

ALPRAZOLAM (ALPRAZOLAM)
0.5MG
Marketing Status: Discontinued

Active Ingredient: ALPRAZOLAM
Proprietary Name: ALPRAZOLAM
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 0.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A078469
Product Number: 001
Approval Date: Sep 29, 2011
Applicant Holder Full Name: ANCHEN PHARMACEUTICALS, INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

ALPRAZOLAM (ALPRAZOLAM)
1MG
Marketing Status: Discontinued

Active Ingredient: ALPRAZOLAM
Proprietary Name: ALPRAZOLAM
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A078469
Product Number: 002
Approval Date: Sep 29, 2011
Applicant Holder Full Name: ANCHEN PHARMACEUTICALS, INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

ALPRAZOLAM (ALPRAZOLAM)
2MG
Marketing Status: Discontinued

Active Ingredient: ALPRAZOLAM
Proprietary Name: ALPRAZOLAM
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A078469
Product Number: 003
Approval Date: Sep 29, 2011
Applicant Holder Full Name: ANCHEN PHARMACEUTICALS, INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

ALPRAZOLAM (ALPRAZOLAM)
3MG
Marketing Status: Discontinued

Active Ingredient: ALPRAZOLAM
Proprietary Name: ALPRAZOLAM
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 3MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A078469
Product Number: 004
Approval Date: Sep 29, 2011
Applicant Holder Full Name: ANCHEN PHARMACEUTICALS, INC
Marketing Status:  Discontinued
Patent and Exclusivity Information