Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075240
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE;INJECTION Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/29/1999 ORIG-1 Approval Letter (PDF)
Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75240ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75240ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/17/2015 SUPPL-13 Labeling

Label is not available on this site.

11/17/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

09/04/2012 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

02/14/2001 SUPPL-1 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

LABETALOL HYDROCHLORIDE

INJECTABLE;INJECTION; 5MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE;INJECTION Prescription No AP 075431 AKORN INC
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE;INJECTION Prescription No AP 075524 AKORN INC
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE;INJECTION Prescription No AP 090699 GLAND PHARMA LTD
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE;INJECTION Prescription No AP 075239 HOSPIRA
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE;INJECTION Prescription No AP 075240 HOSPIRA
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE;INJECTION Prescription No AP 079134 SAGENT AGILA LLC
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE;INJECTION Prescription No AP 075303 WEST-WARD PHARMS INT

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