Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091328
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

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