Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202930
Company: GLAND PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;IV (INFUSION) 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
08/05/2013 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
07/13/2016 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

10/19/2015 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

05/27/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

01/02/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

01/02/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

01/02/2015 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

ZOLEDRONIC ACID

INJECTABLE;IV (INFUSION); 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;IV (INFUSION) Prescription No AP 205279 ACCORD HLTHCARE
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;IV (INFUSION) Prescription No AP 202472 ACTAVIS INC
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;IV (INFUSION) Prescription No AP 202548 AKORN INC
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;IV (INFUSION) Prescription No AP 207751 AUROBINDO PHARMA LTD
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;IV (INFUSION) Prescription No AP 207341 BPI LABS LLC
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;IV (INFUSION) Prescription No AP 091170 BRECKENRIDGE PHARM
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;IV (INFUSION) Prescription No AP 202571 BRECKENRIDGE PHARM
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;IV (INFUSION) Prescription No AP 091186 DR REDDYS LABS LTD
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;IV (INFUSION) Prescription No AP 201783 EMCURE PHARMS LTD
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;IV (INFUSION) Prescription No AP 091516 FRESENIUS KABI USA
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;IV (INFUSION) Prescription No AP 202930 GLAND PHARMA LTD
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;IV (INFUSION) Prescription No AP 202182 HIKMA FARMACEUTICA
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;IV (INFUSION) Prescription No AP 090621 HOSPIRA INC
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;IV (INFUSION) Prescription No AP 202650 MYLAN LABS LTD
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;IV (INFUSION) Prescription No AP 091493 SAGENT PHARMS
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;IV (INFUSION) Prescription No AP 202923 USV NORTH AMERICA
ZOMETA ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;IV (INFUSION) Prescription Yes AP 021223 NOVARTIS

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