Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074787
Company: HERITAGE PHARMA
Company: HERITAGE PHARMA
| 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 |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 400MG | 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 |
|---|---|---|---|---|---|---|---|
| 08/03/1998 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74787_Labetalol%20Hydrochloride_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74787ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074787_labetalol_toc.html |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/26/2026 | SUPPL-59 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/03/2011 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 11/25/2008 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 08/05/2002 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/29/2002 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/05/2002 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/26/2002 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/12/2001 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/05/2002 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/18/2000 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 01/28/2000 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/18/2000 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/25/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/25/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/25/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/25/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/1999 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/03/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74787_Labetalol%20Hydrochloride_Prntlbl.pdf |
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 | 075113 | AIPING PHARM INC |
| 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 | 212990 | EPIC PHARMA LLC |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 074787 | HERITAGE PHARMA |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 207863 | HIBROW HLTHCARE |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 217949 | MACLEODS PHARMS LTD |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 200908 | PH HEALTH |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 211953 | RUBICON RESEARCH |
| 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 | 075113 | AIPING PHARM INC |
| 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 | 212990 | EPIC PHARMA LLC |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 074787 | HERITAGE PHARMA |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 207863 | HIBROW HLTHCARE |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 217949 | MACLEODS PHARMS LTD |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 200908 | PH HEALTH |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 211953 | RUBICON RESEARCH |
| 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 | 075113 | AIPING PHARM INC |
| 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 | 212990 | EPIC PHARMA LLC |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 300MG | TABLET;ORAL | Prescription | No | AB | 074787 | HERITAGE PHARMA |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 300MG | TABLET;ORAL | Prescription | No | AB | 207863 | HIBROW HLTHCARE |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 300MG | TABLET;ORAL | Prescription | No | AB | 217949 | MACLEODS PHARMS LTD |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 300MG | TABLET;ORAL | Prescription | No | AB | 200908 | PH HEALTH |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 300MG | TABLET;ORAL | Prescription | No | AB | 211953 | RUBICON RESEARCH |
| 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 |
TABLET;ORAL; 400MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 400MG | TABLET;ORAL | Prescription | No | AB | 209603 | APPCO |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 400MG | TABLET;ORAL | Prescription | No | AB | 074787 | HERITAGE PHARMA |