Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201446
Company: LUPIN LTD
Company: LUPIN LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FALLBACK SOLO | 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 |
---|---|---|---|---|---|---|---|
06/19/2014 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/13/2016 | SUPPL-2 | Labeling-Container/Carton Labels |
Label is not available on this site. |
FALLBACK SOLO
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 |