Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077067
Company: SUN PHARM INDS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NIMODIPINE NIMODIPINE 30MG 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
04/17/2007 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077067s000_LTR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/18/2012 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

03/30/2010 SUPPL-11 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

NIMODIPINE

CAPSULE;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NIMODIPINE NIMODIPINE 30MG CAPSULE;ORAL Prescription No AB 076740 BIONPHARMA INC
NIMODIPINE NIMODIPINE 30MG CAPSULE;ORAL Prescription No AB 077811 HERITAGE PHARMS INC
NIMODIPINE NIMODIPINE 30MG CAPSULE;ORAL Prescription No AB 201832 SOFGEN PHARMS
NIMODIPINE NIMODIPINE 30MG CAPSULE;ORAL Prescription No AB 077067 SUN PHARM INDS INC
NIMODIPINE NIMODIPINE 30MG CAPSULE;ORAL Prescription No AB 090103 THEPHARMANETWORK LLC

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