Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202837
Company: HOSPIRA INC
Company: HOSPIRA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZOLEDRONIC ACID | ZOLEDRONIC ACID | EQ 5MG BASE/100ML | INJECTABLE;INTRAVENOUS | 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 |
---|---|---|---|---|---|---|---|
04/05/2013 | 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 |
---|---|---|---|---|---|
11/01/2022 | SUPPL-7 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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11/01/2022 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
03/01/2017 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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09/22/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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11/20/2014 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
ZOLEDRONIC ACID
INJECTABLE;INTRAVENOUS; EQ 5MG BASE/100ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RECLAST | ZOLEDRONIC ACID | EQ 5MG BASE/100ML | INJECTABLE;INTRAVENOUS | Prescription | Yes | AP | 021817 | SANDOZ |
ZOLEDRONIC ACID | ZOLEDRONIC ACID | EQ 5MG BASE/100ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 204367 | APOTEX |
ZOLEDRONIC ACID | ZOLEDRONIC ACID | EQ 5MG BASE/100ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 202163 | CHARTWELL RX |
ZOLEDRONIC ACID | ZOLEDRONIC ACID | EQ 5MG BASE/100ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 091363 | DR REDDYS LABS LTD |
ZOLEDRONIC ACID | ZOLEDRONIC ACID | EQ 5MG BASE/100ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 200918 | EPIC PHARMA LLC |
ZOLEDRONIC ACID | ZOLEDRONIC ACID | EQ 5MG BASE/100ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 204217 | GLAND |
ZOLEDRONIC ACID | ZOLEDRONIC ACID | EQ 5MG BASE/100ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 209578 | GLAND PHARMA LTD |
ZOLEDRONIC ACID | ZOLEDRONIC ACID | EQ 5MG BASE/100ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 202837 | HOSPIRA INC |
ZOLEDRONIC ACID | ZOLEDRONIC ACID | EQ 5MG BASE/100ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 202828 | INFORLIFE |
ZOLEDRONIC ACID | ZOLEDRONIC ACID | EQ 5MG BASE/100ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 213371 | MEITHEAL |
ZOLEDRONIC ACID | ZOLEDRONIC ACID | EQ 5MG BASE/100ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203841 | MYLAN LABS LTD |
ZOLEDRONIC ACID | ZOLEDRONIC ACID | EQ 5MG BASE/100ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 205254 | MYLAN LABS LTD |