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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076740
Company: BIONPHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NIMODIPINE NIMODIPINE 30MG CAPSULE;ORAL Prescription AB 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
01/17/2008 ORIG-1 Approval Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/076740Orig1s000BioeqR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/28/2012 SUPPL-4 Labeling-Package Insert

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
NIMODIPINE NIMODIPINE 30MG CAPSULE;ORAL Prescription No AB 077811 HERITAGE PHARMS
NIMODIPINE NIMODIPINE 30MG CAPSULE;ORAL Prescription No AB 090103 THEPHARMANETWORK LLC
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