Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078156
Company: PLIVA LACHEMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE;INJECTION Prescription AP No No
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 60MG/10ML (6MG/ML) INJECTABLE;INJECTION Prescription AP No No
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/19/2008 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/16/2009 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

PAMIDRONATE DISODIUM

INJECTABLE;INJECTION; 30MG/10ML (3MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE;INJECTION Prescription No AP 076207 FRESENIUS KABI USA
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE;INJECTION Prescription No AP 075841 HOSPIRA
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE;INJECTION Prescription No AP 078942 LUITPOLD
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE;INJECTION Prescription No AP 078520 MYLAN LABS LTD
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE;INJECTION Prescription No AP 078156 PLIVA LACHEMA
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE;INJECTION Prescription No AP 078373 SAGENT PHARMS
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE;INJECTION Prescription No AP 076153 TEVA PHARMS USA
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE;INJECTION Prescription Yes AP 021113 WEST-WARD PHARMS INT

INJECTABLE;INJECTION; 60MG/10ML (6MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 60MG/10ML (6MG/ML) INJECTABLE;INJECTION Prescription No AP 075841 HOSPIRA
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 60MG/10ML (6MG/ML) INJECTABLE;INJECTION Prescription No AP 078156 PLIVA LACHEMA

INJECTABLE;INJECTION; 90MG/10ML (9MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE;INJECTION Prescription No AP 076207 FRESENIUS KABI USA
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE;INJECTION Prescription No AP 075841 HOSPIRA
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE;INJECTION Prescription No AP 078942 LUITPOLD
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE;INJECTION Prescription No AP 078520 MYLAN LABS LTD
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE;INJECTION Prescription No AP 078156 PLIVA LACHEMA
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE;INJECTION Prescription No AP 078373 SAGENT PHARMS
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE;INJECTION Prescription No AP 076153 TEVA PHARMS USA
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE;INJECTION Prescription Yes AP 021113 WEST-WARD PHARMS INT

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