Drugs@FDA: FDA-Approved Drugs
Company: ANDAS 5 HOLDING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | AB | No | No |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | AB | No | No |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 300MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
07/29/1999 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75215ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/23/2015 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
12/24/2002 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/16/2002 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/17/2002 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/21/2001 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/02/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
10/02/2000 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/16/2000 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
05/16/2000 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
LABETALOL HYDROCHLORIDE
TABLET;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 075215 | ANDAS 5 HOLDING |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 209603 | APPCO |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 211325 | CADILA PHARMS LTD |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 200908 | ENDO OPERATIONS |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 212990 | EPIC PHARMA LLC |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 207863 | EYWA |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 074787 | HERITAGE PHARMA |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 211953 | RUBICON |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 075113 | SANDOZ |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 075133 | WATSON LABS |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 207743 | ZYDUS PHARMS |
TABLET;ORAL; 200MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 075215 | ANDAS 5 HOLDING |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 209603 | APPCO |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 211325 | CADILA PHARMS LTD |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 200908 | ENDO OPERATIONS |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 212990 | EPIC PHARMA LLC |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 207863 | EYWA |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 074787 | HERITAGE PHARMA |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 211953 | RUBICON |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 075113 | SANDOZ |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 075133 | WATSON LABS |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 207743 | ZYDUS PHARMS |
TABLET;ORAL; 300MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 300MG | TABLET;ORAL | Prescription | No | AB | 075215 | ANDAS 5 HOLDING |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 300MG | TABLET;ORAL | Prescription | No | AB | 209603 | APPCO |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 300MG | TABLET;ORAL | Prescription | No | AB | 211325 | CADILA PHARMS LTD |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 300MG | TABLET;ORAL | Prescription | No | AB | 200908 | ENDO OPERATIONS |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 300MG | TABLET;ORAL | Prescription | No | AB | 212990 | EPIC PHARMA LLC |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 300MG | TABLET;ORAL | Prescription | No | AB | 207863 | EYWA |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 300MG | TABLET;ORAL | Prescription | No | AB | 074787 | HERITAGE PHARMA |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 300MG | TABLET;ORAL | Prescription | No | AB | 211953 | RUBICON |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 300MG | TABLET;ORAL | Prescription | No | AB | 075113 | SANDOZ |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 300MG | TABLET;ORAL | Prescription | No | AB | 075133 | WATSON LABS |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 300MG | TABLET;ORAL | Prescription | No | AB | 207743 | ZYDUS PHARMS |