Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040254
Company: NOVITIUM PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIHEXYPHENIDYL HYDROCHLORIDE TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET;ORAL Prescription AA No No
TRIHEXYPHENIDYL HYDROCHLORIDE TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET;ORAL Prescription AA 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
12/24/1998 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40254_Trihexyphenidyl%20Hydrochloride_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40254ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040254_trihexyphenidyl_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/29/2000 SUPPL-2 Labeling

Label is not available on this site.

09/29/2000 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/24/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40254_Trihexyphenidyl%20Hydrochloride_Prntlbl.pdf

TRIHEXYPHENIDYL HYDROCHLORIDE

TABLET;ORAL; 2MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRIHEXYPHENIDYL HYDROCHLORIDE TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET;ORAL Prescription No AA 091630 NATCO PHARMA LTD
TRIHEXYPHENIDYL HYDROCHLORIDE TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET;ORAL Prescription No AA 040254 NOVITIUM PHARMA
TRIHEXYPHENIDYL HYDROCHLORIDE TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET;ORAL Prescription No AA 084363 WATSON LABS

TABLET;ORAL; 5MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRIHEXYPHENIDYL HYDROCHLORIDE TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 091630 NATCO PHARMA LTD
TRIHEXYPHENIDYL HYDROCHLORIDE TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 040254 NOVITIUM PHARMA
TRIHEXYPHENIDYL HYDROCHLORIDE TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 084364 WATSON LABS

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