Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 040368
Company: IMPAX PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORPHENADRINE CITRATE ORPHENADRINE CITRATE 100MG TABLET, EXTENDED RELEASE;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
06/23/2000 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40368ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/29/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/2001 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/25/2001 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

ORPHENADRINE CITRATE

TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ORPHENADRINE CITRATE ORPHENADRINE CITRATE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 040249 ANDA REPOSITORY
ORPHENADRINE CITRATE ORPHENADRINE CITRATE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 040368 IMPAX PHARMS
ORPHENADRINE CITRATE ORPHENADRINE CITRATE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091158 INVAGEN PHARMS
ORPHENADRINE CITRATE ORPHENADRINE CITRATE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 040284 LUPIN
ORPHENADRINE CITRATE ORPHENADRINE CITRATE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 040327 SANDOZ

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