Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075239
Company: HOSPIRA
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)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75239ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/05/2012 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/075239s010lbl.pdf | |
02/28/2001 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
02/28/2001 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
02/14/2001 | SUPPL-1 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/05/2012 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/075239s010lbl.pdf |
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 | 076051 | BAXTER HLTHCARE CORP |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 5MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214533 | CAPLIN |
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 | 075303 | HIKMA |
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 | 075431 | RISING PHARMA |