Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076153
Company: TEVA PHARMS USA
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 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
03/27/2002 ORIG-1 Approval Letter (PDF)
Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76153.AP.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76153.TA.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/05/2015 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

08/13/2012 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

05/22/2012 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

03/19/2009 SUPPL-8 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 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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