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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212909
Company: DR REDDYS LABS SA

Products on NDA 212909

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BIORPHEN	PHENYLEPHRINE HYDROCHLORIDE	0.5MG/5ML (0.1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes
BIORPHEN	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212909

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/21/2019	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212909s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212909Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212909Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/12/2024	SUPPL-2	Manufacturing (CMC)-Facility	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212909Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212909Orig1s002ltr.pdf
03/11/2021	SUPPL-1	Efficacy-Manufacturing Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212909Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212909Orig1s001ltr.pdf

Labels for NDA 212909

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/12/2024	SUPPL-2	Manufacturing (CMC)-Facility	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212909Orig1s002lbl.pdf
03/11/2021	SUPPL-1	Efficacy-Manufacturing Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212909Orig1s001lbl.pdf
10/21/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212909s000lbl.pdf

Therapeutic Equivalents for NDA 212909

BIORPHEN

SOLUTION;INTRAVENOUS; 0.5MG/5ML (0.1MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BIORPHEN	PHENYLEPHRINE HYDROCHLORIDE	0.5MG/5ML (0.1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	212909	DR REDDYS LABS SA
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	0.5MG/5ML (0.1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	215617	SOMERSET THERAPS LLC

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