Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202684
Company: LOTUS PHARM CO LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVONORGESTREL LEVONORGESTREL 0.75MG TABLET;ORAL Prescription 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
09/02/2016 ORIG-1 Approval

Label is not available on this site.

LEVONORGESTREL

TABLET;ORAL; 0.75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVONORGESTREL LEVONORGESTREL 0.75MG TABLET;ORAL Prescription No AB 202684 LOTUS PHARM CO LTD
LEVONORGESTREL LEVONORGESTREL 0.75MG TABLET;ORAL Prescription No AB 202740 MYLAN LABS LTD
LEVONORGESTREL LEVONORGESTREL 0.75MG TABLET;ORAL Prescription No AB 090740 PERRIGO R AND D

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 202684 LOTUS PHARM CO LTD
LEVONORGESTREL LEVONORGESTREL 0.75MG TABLET;ORAL Over-the-counter No 202740 MYLAN LABS LTD
LEVONORGESTREL LEVONORGESTREL 0.75MG TABLET;ORAL Over-the-counter No 090740 PERRIGO R AND D

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