Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091328
Company: LUPIN LTD
Company: LUPIN LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVONORGESTREL | LEVONORGESTREL | 0.75MG | TABLET;ORAL | Discontinued | None | No | No |
LEVONORGESTREL | LEVONORGESTREL | 0.75MG | 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 |
---|---|---|---|---|---|---|---|
01/23/2013 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2013/091328Orig1s000.pdf |
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; 0.75MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
LEVONORGESTREL | LEVONORGESTREL | 0.75MG | TABLET; ORAL | Over-the-counter | No | 091328 | LUPIN LTD |