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FDA Orange Book · active-ingredient family

Pamidronate disodium

Pamidronate disodium is approved as 2 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:PAMIDRONATE DISODIUM · NDA 021113

2

Brand (NDA)

13

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable

ProductApplicantApplicationTEApproved
PAMIDRONATE DISODIUMRLD×2HIKMANDA 021113AP1Mar 04, 2002
AREDIARLD×3NOVARTISNDA 020036—Oct 31, 1991

Generic (ANDA) products (13)

ProductApplicantApplicationTEApproved
PAMIDRONATE DISODIUM×2MN PHARMSANDA 078300—Mar 10, 2009
PAMIDRONATE DISODIUM×2SUN PHARMA GLOBALANDA 077703—Dec 24, 2008
PAMIDRONATE DISODIUM×2SAGENT PHARMS INCANDA 078373AP1Dec 23, 2008
PAMIDRONATE DISODIUM×3AREVA PHARMSANDA 077433APNov 26, 2008
PAMIDRONATE DISODIUM×2MYLAN LABS LTDANDA 078520AP2Oct 31, 2008
PAMIDRONATE DISODIUM×3DR REDDYSANDA 078156AP2Aug 19, 2008
PAMIDRONATE DISODIUM×2AM REGENTANDA 078942—Jul 25, 2008
PAMIDRONATE DISODIUM×3HOSPIRAANDA 075841AP2Jun 27, 2002
PAMIDRONATE DISODIUM×2FRESENIUS KABI USAANDA 076207—May 17, 2002
PAMIDRONATE DISODIUM×2AESGENANDA 075594—May 06, 2002
PAMIDRONATE DISODIUM×2FRESENIUS KABI USAANDA 075773—May 06, 2002
PAMIDRONATE DISODIUM×2TEVA PHARMS USAANDA 076153—Mar 27, 2002
PAMIDRONATE DISODIUM×2HIKMAANDA 075290APApr 30, 2001

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Pamidronate disodium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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