Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090618
Company: GLENMARK GENERICS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NIZATIDINE NIZATIDINE 150MG CAPSULE;ORAL Prescription AB No No
NIZATIDINE NIZATIDINE 300MG CAPSULE;ORAL Prescription AB 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
07/15/2011 ORIG-1 Approval

Label is not available on this site.

NIZATIDINE

CAPSULE;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NIZATIDINE NIZATIDINE 150MG CAPSULE;ORAL Prescription No AB 075668 ANI PHARMS INC
NIZATIDINE NIZATIDINE 150MG CAPSULE;ORAL Prescription No AB 077314 DR REDDYS LABS LTD
NIZATIDINE NIZATIDINE 150MG CAPSULE;ORAL Prescription No AB 090618 GLENMARK GENERICS
NIZATIDINE NIZATIDINE 150MG CAPSULE;ORAL Prescription No AB 075806 MYLAN PHARMS INC
NIZATIDINE NIZATIDINE 150MG CAPSULE;ORAL Prescription No AB 076178 SANDOZ
NIZATIDINE NIZATIDINE 150MG CAPSULE;ORAL Prescription No AB 075616 WATSON LABS

CAPSULE;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NIZATIDINE NIZATIDINE 300MG CAPSULE;ORAL Prescription No AB 075668 ANI PHARMS INC
NIZATIDINE NIZATIDINE 300MG CAPSULE;ORAL Prescription No AB 077314 DR REDDYS LABS LTD
NIZATIDINE NIZATIDINE 300MG CAPSULE;ORAL Prescription No AB 090618 GLENMARK GENERICS
NIZATIDINE NIZATIDINE 300MG CAPSULE;ORAL Prescription No AB 075806 MYLAN PHARMS INC
NIZATIDINE NIZATIDINE 300MG CAPSULE;ORAL Prescription No AB 076178 SANDOZ
NIZATIDINE NIZATIDINE 300MG CAPSULE;ORAL Prescription No AB 075616 WATSON LABS

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