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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040249
Company: RISING

Products on ANDA 040249

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040249

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/29/1999	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40249_Orphenadrine%20Citrate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40249ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/040249_orphenadrine_toc.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/14/2024	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 040249

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/29/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40249_Orphenadrine%20Citrate_Prntlbl.pdf

Therapeutic Equivalents for ANDA 040249

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	040284	LUPIN
ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	040249	RISING
ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	040327	SANDOZ
ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	091158	UNICHEM

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