Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075431
Company: RISING PHARMA
Company: RISING PHARMA
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 | 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 |
---|---|---|---|---|---|---|---|
11/29/1999 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75431ltr.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 |