Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021998
Company: FDN CONSUMER
Company: FDN CONSUMER
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 |
---|---|---|---|---|---|
01/04/2019 | SUPPL-6 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021998Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021998Orig1s006ltr.pdf | |
12/23/2022 | SUPPL-5 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021998Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021998Orig1s005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021998Orig1s005SumR.pdf | |
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 |
---|---|---|---|---|---|
12/23/2022 | SUPPL-5 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021998Orig1s005lbl.pdf | |
01/04/2019 | SUPPL-6 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021998Orig1s006lbl.pdf | |
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 |
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 | 202380 | NAARI PTE LTD |
LEVONORGESTREL | LEVONORGESTREL | 1.5MG | TABLET;ORAL | Over-the-counter | No | 207660 | 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 | 202739 | XIROMED |
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 |