Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 204398
Company: AKORN INC
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 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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English