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PAMIDRONATE DISODIUM

ANDA

PAMIDRONATE DISODIUM | A076153 | TEVA PHARMACEUTICALS USA

2 strengths0 unique patents0 unique exclusivities

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

GADOR SAPAMIDRONATE DISODIUM

DMF 394422025

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Apr 11, 2003	ORIG -1	View Letter (PDF)
Apr 10, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — 30MG/10ML (3MG/ML)

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Mar 27, 2002

No patent or exclusivity listings for this strength.

#002 — 90MG/10ML (9MG/ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Mar 27, 2002