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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214074
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION;INJECTION Prescription AP No No
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION;INJECTION Prescription AP No No
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION;INJECTION Prescription AP No No
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION;INJECTION Prescription AP 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
07/20/2020 ORIG-1 Approval STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/09/2024 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

ROPIVACAINE HYDROCHLORIDE

SOLUTION;INJECTION; 40MG/20ML (2MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NAROPIN ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION;INJECTION Prescription Yes AP 020533 FRESENIUS KABI USA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION;INJECTION Prescription No AP 219883 ANTHEA PHARMA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION;INJECTION Prescription No AP 212808 CAPLIN
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION;INJECTION Prescription No AP 205612 EUGIA PHARMA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION;INJECTION Prescription No AP 214074 HIKMA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION;INJECTION Prescription No AP 218713 KINDOS
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION;INJECTION Prescription No AP 207636 SOMERSET THERAPS LLC

SOLUTION;INJECTION; 150MG/30ML (5MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NAROPIN ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION;INJECTION Prescription Yes AP 020533 FRESENIUS KABI USA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION;INJECTION Prescription No AP 219883 ANTHEA PHARMA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION;INJECTION Prescription No AP 212808 CAPLIN
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION;INJECTION Prescription No AP 205612 EUGIA PHARMA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION;INJECTION Prescription No AP 214074 HIKMA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION;INJECTION Prescription No AP 218713 KINDOS
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION;INJECTION Prescription No AP 078601 NAVINTA LLC
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION;INJECTION Prescription No AP 203955 RISING
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION;INJECTION Prescription No AP 207636 SOMERSET THERAPS LLC

SOLUTION;INJECTION; 150MG/20ML (7.5MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NAROPIN ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION;INJECTION Prescription Yes AP 020533 FRESENIUS KABI USA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION;INJECTION Prescription No AP 205612 EUGIA PHARMA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION;INJECTION Prescription No AP 214074 HIKMA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION;INJECTION Prescription No AP 218713 KINDOS
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION;INJECTION Prescription No AP 207636 SOMERSET THERAPS LLC

SOLUTION;INJECTION; 200MG/20ML (10MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NAROPIN ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION;INJECTION Prescription Yes AP 020533 FRESENIUS KABI USA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION;INJECTION Prescription No AP 219883 ANTHEA PHARMA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION;INJECTION Prescription No AP 212808 CAPLIN
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION;INJECTION Prescription No AP 205612 EUGIA PHARMA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION;INJECTION Prescription No AP 214074 HIKMA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION;INJECTION Prescription No AP 218713 KINDOS
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION;INJECTION Prescription No AP 078601 NAVINTA LLC
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION;INJECTION Prescription No AP 207636 SOMERSET THERAPS LLC
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