Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078156

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PAMIDRONATE DISODIUM (PAMIDRONATE DISODIUM)
30MG/10ML (3MG/ML)
Marketing Status: Prescription

Active Ingredient: PAMIDRONATE DISODIUM
Proprietary Name: PAMIDRONATE DISODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 30MG/10ML (3MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP2
Application Number: A078156
Product Number: 001
Approval Date: Aug 19, 2008
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

PAMIDRONATE DISODIUM (PAMIDRONATE DISODIUM)
60MG/10ML (6MG/ML)
Marketing Status: Prescription

Active Ingredient: PAMIDRONATE DISODIUM
Proprietary Name: PAMIDRONATE DISODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 60MG/10ML (6MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A078156
Product Number: 002
Approval Date: Aug 19, 2008
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

PAMIDRONATE DISODIUM (PAMIDRONATE DISODIUM)
90MG/10ML (9MG/ML)
Marketing Status: Prescription

Active Ingredient: PAMIDRONATE DISODIUM
Proprietary Name: PAMIDRONATE DISODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 90MG/10ML (9MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP2
Application Number: A078156
Product Number: 003
Approval Date: Aug 19, 2008
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information