Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021113
Company: HIKMA
Company: HIKMA
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 | AP1 | Yes | Yes |
PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 90MG/10ML (9MG/ML) | INJECTABLE;INJECTION | Prescription | AP1 | 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 = AP1
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 | Yes | AP1 | 021113 | HIKMA |
PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 30MG/10ML (3MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP1 | 078373 | SAGENT PHARMS INC |
INJECTABLE;INJECTION; 90MG/10ML (9MG/ML)
TE Code = AP1
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 | Yes | AP1 | 021113 | HIKMA |
PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 90MG/10ML (9MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP1 | 078373 | SAGENT PHARMS INC |