Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202508
Company: NOVEL LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVONORGESTREL LEVONORGESTREL 1.5MG TABLET;ORAL Over-the-counter None 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
02/22/2013 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
06/03/2016 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

03/19/2014 SUPPL-3 Labeling-Container/Carton Labels

Label is not available on this site.

03/19/2014 SUPPL-1 Labeling-Medication Guide

Label is not available on this site.

LEVONORGESTREL

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; 1.5MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ATHENTIA NEXT LEVONORGESTREL 1.5MG TABLET;ORAL Over-the-counter No 206867 AUROBINDO PHARMA LTD
FALLBACK SOLO LEVONORGESTREL 1.5MG TABLET;ORAL Over-the-counter No 201446 LUPIN LTD
HER STYLE LEVONORGESTREL 1.5MG TABLET;ORAL Over-the-counter No 207976 NOVAST LABS LTD
LEVONORGESTREL LEVONORGESTREL 1.5MG TABLET;ORAL Over-the-counter No 207044 GLENMARK PHARMS LTD
LEVONORGESTREL LEVONORGESTREL 1.5MG TABLET;ORAL Over-the-counter No 202739 MYLAN LABS LTD
LEVONORGESTREL LEVONORGESTREL 1.5MG TABLET;ORAL Over-the-counter No 202508 NOVEL LABS INC
LEVONORGESTREL LEVONORGESTREL 1.5MG TABLET;ORAL Over-the-counter No 202380 OC PHARMA
LEVONORGESTREL LEVONORGESTREL 1.5MG TABLET;ORAL Over-the-counter No 202334 PERRIGO R AND D
LEVONORGESTREL LEVONORGESTREL 1.5MG TABLET;ORAL Over-the-counter No 202246 RECKITT BENCKISER
LEVONORGESTREL LEVONORGESTREL 1.5MG TABLET;ORAL Over-the-counter No 200670 WATSON LABS INC
OPCICON ONE-STEP LEVONORGESTREL 1.5MG TABLET;ORAL Over-the-counter No 202635 SUN PHARM INDS LTD
PLAN B ONE-STEP LEVONORGESTREL 1.5MG TABLET;ORAL Over-the-counter Yes 021998 TEVA BRANDED PHARM

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