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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217178
Company: LONG GROVE PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIAZEPAM DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE;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
12/31/2024 ORIG-1 Approval STANDARD

Label is not available on this site.

DIAZEPAM

INJECTABLE;INJECTION; 10MG/2ML (5MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIAZEPAM DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE;INJECTION Prescription No AP 218450 ALEMBIC
DIAZEPAM DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE;INJECTION Prescription No AP 218422 DR REDDYS
DIAZEPAM DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE;INJECTION Prescription No AP 214745 FRESENIUS KABI USA
DIAZEPAM DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE;INJECTION Prescription No AP 070313 HIKMA
DIAZEPAM DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE;INJECTION Prescription No AP 072079 HOSPIRA
DIAZEPAM DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE;INJECTION Prescription No AP 217178 LONG GROVE PHARMS
DIAZEPAM DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE;INJECTION Prescription No AP 210363 REGCON HOLDINGS
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