Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075841
Company: HOSPIRA

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 Yes
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 60MG/10ML (6MG/ML) INJECTABLE;INJECTION Prescription AP No Yes
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE;INJECTION Prescription AP No Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/27/2002 ORIG-1 Approval Review

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075841_s000_PamidronateTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/07/2020 SUPPL-19 Labeling-Package Insert

Label is not available on this site.
07/15/2009 SUPPL-16 Labeling

Label is not available on this site.
07/09/2008 SUPPL-14 Labeling

Label is not available on this site.
01/19/2007 SUPPL-10 Labeling

Label is not available on this site.
07/14/2006 SUPPL-9 Labeling

Label is not available on this site.
05/19/2006 SUPPL-7 Labeling

Label is not available on this site.
01/21/2005 SUPPL-2 Labeling

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 078156 DR REDDYS
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 078520 MYLAN LABS LTD
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE;INJECTION Prescription No AP 078373 SAGENT PHARMS INC
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 078156 DR REDDYS
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 60MG/10ML (6MG/ML) INJECTABLE;INJECTION Prescription No AP 075841 HOSPIRA

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 078156 DR REDDYS
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 078520 MYLAN LABS LTD
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE;INJECTION Prescription No AP 078373 SAGENT PHARMS INC
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE;INJECTION Prescription Yes AP 021113 WEST-WARD PHARMS INT

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