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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091340
Company: CHARTWELL RX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRAVOPROST TRAVOPROST 0.004% SOLUTION/DROPS;OPHTHALMIC Prescription AT1 No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/01/2013 ORIG-1 Approval

Label is not available on this site.

TRAVOPROST

SOLUTION/DROPS;OPHTHALMIC; 0.004%
TE Code = AT1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRAVOPROST TRAVOPROST 0.004% SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 210458 ALEMBIC
TRAVOPROST TRAVOPROST 0.004% SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 091340 CHARTWELL RX
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