Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075290
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 30MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 90MG/VIAL | 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 |
---|---|---|---|---|---|---|---|
04/30/2001 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-290_Pamidronate%20Disodium_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75290ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-290_Pamidronate.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/08/2012 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
05/17/2012 | SUPPL-18 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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09/09/2009 | SUPPL-14 | Labeling |
Label is not available on this site. |
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07/24/2008 | SUPPL-11 | Labeling |
Label is not available on this site. |
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09/23/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
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07/19/2005 | SUPPL-8 | Labeling |
Label is not available on this site. |
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05/11/2005 | SUPPL-6 | Labeling |
Label is not available on this site. |
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05/18/2004 | SUPPL-4 | Labeling |
Label is not available on this site. |
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11/07/2002 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/30/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-290_Pamidronate%20Disodium_prntlbl.pdf |
PAMIDRONATE DISODIUM
INJECTABLE;INJECTION; 30MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 30MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 077433 | AREVA PHARMS |
PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 30MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 075290 | HIKMA |
INJECTABLE;INJECTION; 90MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 90MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 077433 | AREVA PHARMS |
PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 90MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 075290 | HIKMA |