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Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

IBANDRONATE SODIUM

ANDA

Tentative Approval

IBANDRONATE SODIUM | A079002 | COBALT LABS INC

API Supply Chain10 active DMFs1 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

APITORIA PHARMA PRIVATE LTDIBANDRONATE SODIUM (NON-STERILE DRUG SUBSTANCE)

DMF 203932007

NATCO PHARMA LTDIBANDRONATE SODIUM MONOHYDRATE

DMF 204112007

ORBION PHARMACEUTICALS PRIVATE LTDIBANDRONATE SODIUM

DMF 204222007

DR REDDYS LABORATORIES LTDIBANDRONATE SODIUM MONOHYDRATE

DMF 204662007

APOTEX INCIBANDRONATE SODIUM

DMF 205252007

DR REDDYS LABORATORIES LTDIBANDRONATE SODIUM (FORM-BETA)

DMF 223002008

NATCO PHARMA LTDIBANDRONATE SODIUM MONOHYDRATE (INJECTABLE GRADE)

DMF 248242011

EMCURE PHARMACEUTICALS LTDIBANDRONATE SODIUM MONOHYDRATE

DMF 251722011

ZAKLADY FARMACEUTYCZNE POLPHARMA SAIBANDRONATE SODIUM MONOHYDRATE

DMF 256382011

MACLEODS PHARMACEUTICALS LTDIBANDRONATE SODIUM MONOHYDRATE

DMF 257932012

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveIBANDRONATE SODIUM

DMF 204942007

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 2.5MG

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TABLET; ORAL | TA Date: 2011-03-15 00:00:00

No patent or exclusivity listings for this strength.