U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 204398
Company: RISING
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
09/27/2017 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204398Orig1s000ltr.pdf

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 SANDOZ
PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE 1% SOLUTION;OPHTHALMIC Prescription No AT 214193 AMNEAL
PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE 1% SOLUTION;OPHTHALMIC Prescription No AT 204398 RISING
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 SANDOZ
PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE 2% SOLUTION;OPHTHALMIC Prescription No AT 214193 AMNEAL
PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE 2% SOLUTION;OPHTHALMIC Prescription No AT 204398 RISING
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 SANDOZ
PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE 4% SOLUTION;OPHTHALMIC Prescription No AT 214193 AMNEAL
PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE 4% SOLUTION;OPHTHALMIC Prescription No AT 204398 RISING
PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE 4% SOLUTION;OPHTHALMIC Prescription No AT 210384 SOMERSET THERAPS LLC
Back to Top