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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210384
Company: SOMERSET THERAPS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE 1% SOLUTION;OPHTHALMIC Prescription AT No No
PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE 2% SOLUTION;OPHTHALMIC Prescription AT No No
PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE 4% SOLUTION;OPHTHALMIC Prescription AT 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
11/25/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

PILOCARPINE HYDROCHLORIDE

SOLUTION;OPHTHALMIC; 1%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ISOPTO CARPINE PILOCARPINE HYDROCHLORIDE 1% SOLUTION;OPHTHALMIC Prescription Yes AT 200890 NOVARTIS
PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE 1% SOLUTION;OPHTHALMIC Prescription No AT 204398 AKORN
PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE 1% SOLUTION;OPHTHALMIC Prescription No AT 214193 AMNEAL
PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE 1% SOLUTION;OPHTHALMIC Prescription No AT 210384 SOMERSET THERAPS LLC

SOLUTION;OPHTHALMIC; 2%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ISOPTO CARPINE PILOCARPINE HYDROCHLORIDE 2% SOLUTION;OPHTHALMIC Prescription Yes AT 200890 NOVARTIS
PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE 2% SOLUTION;OPHTHALMIC Prescription No AT 204398 AKORN
PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE 2% SOLUTION;OPHTHALMIC Prescription No AT 214193 AMNEAL
PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE 2% SOLUTION;OPHTHALMIC Prescription No AT 210384 SOMERSET THERAPS LLC

SOLUTION;OPHTHALMIC; 4%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ISOPTO CARPINE PILOCARPINE HYDROCHLORIDE 4% SOLUTION;OPHTHALMIC Prescription Yes AT 200890 NOVARTIS
PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE 4% SOLUTION;OPHTHALMIC Prescription No AT 204398 AKORN
PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE 4% SOLUTION;OPHTHALMIC Prescription No AT 214193 AMNEAL
PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE 4% SOLUTION;OPHTHALMIC Prescription No AT 210384 SOMERSET THERAPS LLC
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