Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071972
Company: IMPAX LABS INC
Company: IMPAX LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | AB | No | No |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | AB | No | No |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 40MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/06/1988 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/22/2015 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/09/2014 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/07/2008 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 03/20/2008 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 05/24/2002 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 06/08/2001 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/22/1999 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/10/1999 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 10/20/1998 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 05/11/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 10/24/1991 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 08/30/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
PROPRANOLOL HYDROCHLORIDE
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 071972 | IMPAX LABS INC |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 070322 | INNOGENIX |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 078955 | IPCA LABS LTD |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 070213 | MYLAN |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 078213 | NORTHSTAR HLTHCARE |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 070221 | VINTAGE PHARMS |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 070175 | WATSON LABS |
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 071972 | IMPAX LABS INC |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 070322 | INNOGENIX |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 078955 | IPCA LABS LTD |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 070213 | MYLAN |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 078213 | NORTHSTAR HLTHCARE |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 070221 | VINTAGE PHARMS |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 070176 | WATSON LABS |
TABLET;ORAL; 40MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 071972 | IMPAX LABS INC |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 070322 | INNOGENIX |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 078955 | IPCA LABS LTD |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 070213 | MYLAN |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 078213 | NORTHSTAR HLTHCARE |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 070219 | VINTAGE PHARMS |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 070221 | VINTAGE PHARMS |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 070177 | WATSON LABS |