Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091186
Company: DR REDDYS LABS LTD
Company: DR REDDYS LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZOLEDRONIC ACID | ZOLEDRONIC ACID | EQ 4MG BASE/5ML | INJECTABLE;INTRAVENOUS | Prescription | AP | No | 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 |
---|---|---|---|---|---|---|---|
03/04/2013 | 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 |
---|---|---|---|---|---|
02/21/2020 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
02/21/2020 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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07/11/2016 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
09/21/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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03/06/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
03/06/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
03/06/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
ZOLEDRONIC ACID
INJECTABLE;INTRAVENOUS; EQ 4MG BASE/5ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ZOLEDRONIC ACID | ZOLEDRONIC ACID | EQ 4MG BASE/5ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 205279 | ACCORD HLTHCARE |
ZOLEDRONIC ACID | ZOLEDRONIC ACID | EQ 4MG BASE/5ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 201783 | AVET LIFESCIENCES |
ZOLEDRONIC ACID | ZOLEDRONIC ACID | EQ 4MG BASE/5ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 207341 | BPI LABS |
ZOLEDRONIC ACID | ZOLEDRONIC ACID | EQ 4MG BASE/5ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 202571 | CHARTWELL RX |
ZOLEDRONIC ACID | ZOLEDRONIC ACID | EQ 4MG BASE/5ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 091186 | DR REDDYS LABS LTD |
ZOLEDRONIC ACID | ZOLEDRONIC ACID | EQ 4MG BASE/5ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 202548 | EPIC PHARMA LLC |
ZOLEDRONIC ACID | ZOLEDRONIC ACID | EQ 4MG BASE/5ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 091516 | FRESENIUS KABI USA |
ZOLEDRONIC ACID | ZOLEDRONIC ACID | EQ 4MG BASE/5ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 202930 | GLAND PHARMA LTD |
ZOLEDRONIC ACID | ZOLEDRONIC ACID | EQ 4MG BASE/5ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 202182 | HIKMA FARMACEUTICA |
ZOLEDRONIC ACID | ZOLEDRONIC ACID | EQ 4MG BASE/5ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 202650 | MYLAN LABS LTD |
ZOLEDRONIC ACID | ZOLEDRONIC ACID | EQ 4MG BASE/5ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 091493 | SAGENT PHARMS INC |
ZOLEDRONIC ACID | ZOLEDRONIC ACID | EQ 4MG BASE/5ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 202923 | USV |