Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076746
Company: PERRIGO PHARMA INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription AB 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
11/16/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76746ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/25/2011 SUPPL-2 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

06/29/2005 SUPPL-1 Labeling

Label is not available on this site.

PILOCARPINE HYDROCHLORIDE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 212377 AUROBINDO PHARMA LTD
PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 077248 IMPAX LABS
PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 076963 INNOGENIX
PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 077220 LANNETT CO INC
PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 076746 PERRIGO PHARMA INTL
SALAGEN PILOCARPINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription Yes AB 020237 CONCORDIA

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