Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021998
Company: TEVA BRANDED PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PLAN B ONE-STEP LEVONORGESTREL 1.5MG TABLET;ORAL Over-the-counter None Yes 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
07/10/2009 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021998lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021998s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021998_planb_onestep_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021998s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/10/2017 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021998Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021998Orig1s004ltr.pdf
06/20/2013 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021998Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021998Orig1s003ltr.pdf
04/30/2013 SUPPL-2 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021998Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021998Orig1s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021998Orig1s002.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/10/2017 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021998Orig1s004lbl.pdf
06/20/2013 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021998Orig1s003lbl.pdf
04/30/2013 SUPPL-2 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021998Orig1s002lbl.pdf
07/10/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021998lbl.pdf

PLAN B ONE-STEP

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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