Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 200890
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOPTO CARPINE PILOCARPINE HYDROCHLORIDE 1% SOLUTION;OPHTHALMIC Prescription AT Yes No
ISOPTO CARPINE PILOCARPINE HYDROCHLORIDE 2% SOLUTION;OPHTHALMIC Prescription AT Yes No
ISOPTO CARPINE PILOCARPINE HYDROCHLORIDE 4% SOLUTION;OPHTHALMIC Prescription AT Yes 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
06/22/2010 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200890s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200890s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200890_carpine_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200890s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/12/2014 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/27/2014 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/07/2013 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/08/2010 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200890s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200890s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/08/2010 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200890s001lbl.pdf
06/22/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200890s000lbl.pdf

ISOPTO CARPINE

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 INC

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 INC

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 INC

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