Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 090788

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DIDANOSINE (DIDANOSINE)
125MG
Marketing Status: Discontinued

Active Ingredient: DIDANOSINE
Proprietary Name: DIDANOSINE
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: 125MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A090788
Product Number: 001
Approval Date: Apr 8, 2010
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

DIDANOSINE (DIDANOSINE)
200MG
Marketing Status: Discontinued

Active Ingredient: DIDANOSINE
Proprietary Name: DIDANOSINE
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A090788
Product Number: 002
Approval Date: Apr 8, 2010
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

DIDANOSINE (DIDANOSINE)
250MG
Marketing Status: Discontinued

Active Ingredient: DIDANOSINE
Proprietary Name: DIDANOSINE
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: 250MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A090788
Product Number: 003
Approval Date: Apr 8, 2010
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

DIDANOSINE (DIDANOSINE)
400MG
Marketing Status: Discontinued

Active Ingredient: DIDANOSINE
Proprietary Name: DIDANOSINE
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: 400MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A090788
Product Number: 004
Approval Date: Apr 8, 2010
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information