Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040277
Company: RISING

Products on ANDA 040277

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROPARACAINE HYDROCHLORIDE	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040277

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/16/2000	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40277_Proparacaine%20Hydrochloride%20Ophthalmic_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40277ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/040277_proparacaine_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/23/2001	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.

Labels for ANDA 040277

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/16/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40277_Proparacaine%20Hydrochloride%20Ophthalmic_Prntlbl.pdf

Therapeutic Equivalents for ANDA 040277

PROPARACAINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC; 0.5%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALCAINE	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	080027	ALCON LABS INC
PROPARACAINE HYDROCHLORIDE	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	040074	BAUSCH AND LOMB
PROPARACAINE HYDROCHLORIDE	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	040277	RISING