Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075841
Company: HOSPIRA
Company: HOSPIRA
| 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 | AP2 | No | No |
| PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 60MG/10ML (6MG/ML) | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
| PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 90MG/10ML (9MG/ML) | INJECTABLE;INJECTION | Prescription | AP2 | 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 |
|---|---|---|---|---|---|---|---|
| 06/27/2002 | ORIG-1 | Approval |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075841_s000_PamidronateTOC.html |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/07/2020 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/15/2009 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 07/09/2008 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 01/19/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 07/14/2006 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 05/19/2006 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 01/21/2005 | SUPPL-2 | Labeling |
Label is not available on this site. |
PAMIDRONATE DISODIUM
INJECTABLE;INJECTION; 30MG/10ML (3MG/ML)
TE Code = AP2
| 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 | AP2 | 078156 | DR REDDYS |
| PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 30MG/10ML (3MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP2 | 075841 | HOSPIRA |
| PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 30MG/10ML (3MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP2 | 078520 | MYLAN LABS LTD |
INJECTABLE;INJECTION; 60MG/10ML (6MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 60MG/10ML (6MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078156 | DR REDDYS |
| PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 60MG/10ML (6MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 075841 | HOSPIRA |
INJECTABLE;INJECTION; 90MG/10ML (9MG/ML)
TE Code = AP2
| 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 | AP2 | 078156 | DR REDDYS |
| PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 90MG/10ML (9MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP2 | 075841 | HOSPIRA |
| PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 90MG/10ML (9MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP2 | 078520 | MYLAN LABS LTD |