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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216935
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISOLONE ACETATE PREDNISOLONE ACETATE 1% SUSPENSION/DROPS;OPHTHALMIC Prescription AB 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
08/02/2024 ORIG-1 Approval STANDARD

Label is not available on this site.

PREDNISOLONE ACETATE

SUSPENSION/DROPS;OPHTHALMIC; 1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OMNIPRED PREDNISOLONE ACETATE 1% SUSPENSION/DROPS;OPHTHALMIC Prescription Yes AB 017469 SANDOZ
PRED FORTE PREDNISOLONE ACETATE 1% SUSPENSION/DROPS;OPHTHALMIC Prescription Yes AB 017011 ABBVIE
PREDNISOLONE ACETATE PREDNISOLONE ACETATE 1% SUSPENSION/DROPS;OPHTHALMIC Prescription No AB 218256 AMNEAL
PREDNISOLONE ACETATE PREDNISOLONE ACETATE 1% SUSPENSION/DROPS;OPHTHALMIC Prescription No AB 216935 LUPIN LTD
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