Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076207
Company: FRESENIUS KABI 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
05/17/2002 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
07/02/2015 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

05/21/2012 SUPPL-11 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/18/2008 SUPPL-7 Labeling

Label is not available on this site.

02/23/2007 SUPPL-6 Labeling

Label is not available on this site.

11/29/2005 SUPPL-4 Labeling

Label is not available on this site.

01/21/2005 SUPPL-3 Labeling

Label is not available on this site.

02/13/2004 SUPPL-1 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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English