Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202380
Company: NAARI PTE LTD
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
05/29/2015 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
09/13/2016 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

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
LEVONORGESTREL LEVONORGESTREL 1.5MG TABLET;ORAL Over-the-counter No 207044 GLENMARK PHARMS LTD
LEVONORGESTREL LEVONORGESTREL 1.5MG TABLET;ORAL Over-the-counter No 204044 LABORATOIRE HRA
LEVONORGESTREL LEVONORGESTREL 1.5MG TABLET;ORAL Over-the-counter No 202739 MYLAN LABS LTD
LEVONORGESTREL LEVONORGESTREL 1.5MG TABLET;ORAL Over-the-counter No 202380 NAARI PTE 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 202334 PERRIGO R AND D
LEVONORGESTREL LEVONORGESTREL 1.5MG TABLET;ORAL Over-the-counter No 205329 XIROMED
OPCICON ONE-STEP LEVONORGESTREL 1.5MG TABLET;ORAL Over-the-counter No 202635 SUN PHARM
PLAN B ONE-STEP LEVONORGESTREL 1.5MG TABLET;ORAL Over-the-counter Yes 021998 FDN CONSUMER

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