Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021113
Company: WEST-WARD PHARMS INT
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 Yes Yes
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE;INJECTION Prescription AP Yes 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
03/04/2002 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-113_Pamidronate.htm https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21113ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-113_Pamidronate.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/04/2014 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021113s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021113Orig1s017ltr.pdf
10/18/2012 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021113s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021113Orig1s012ltr.pdf
07/27/2009 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021113s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021113s008ltr.pdf
10/17/2008 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021113s006ltr.pdf
11/14/2005 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021113s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021113s004ltr.pdf
09/29/2004 SUPPL-2 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21113s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/04/2014 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021113s017lbl.pdf
10/18/2012 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021113s012lbl.pdf
07/27/2009 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021113s008lbl.pdf
11/14/2005 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021113s004lbl.pdf
03/04/2002 ORIG-1 Approval https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-113_Pamidronate.htm

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 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; 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 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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