Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 075286

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PEMOLINE (PEMOLINE)
18.75MG
Marketing Status: Discontinued

Active Ingredient: PEMOLINE
Proprietary Name: PEMOLINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 18.75MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A075286
Product Number: 001
Approval Date: Dec 27, 1999
Applicant Holder Full Name: FOSUN PHARMA USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

PEMOLINE (PEMOLINE)
37.5MG
Marketing Status: Discontinued

Active Ingredient: PEMOLINE
Proprietary Name: PEMOLINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 37.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A075286
Product Number: 002
Approval Date: Jun 30, 1999
Applicant Holder Full Name: FOSUN PHARMA USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

PEMOLINE (PEMOLINE)
75MG
Marketing Status: Discontinued

Active Ingredient: PEMOLINE
Proprietary Name: PEMOLINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 75MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A075286
Product Number: 003
Approval Date: Jun 30, 1999
Applicant Holder Full Name: FOSUN PHARMA USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information