Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070213
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | AB | No | No |
| 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 | 80MG | TABLET;ORAL | Prescription | AB | No | No |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 60MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/19/1985 | 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 |
|---|---|---|---|---|---|
| 06/07/2021 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/05/2004 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 04/03/2002 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 11/24/1999 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 08/10/1998 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 02/25/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1998 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/16/1993 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/02/1992 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1991 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 08/23/1990 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 05/11/1990 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 08/07/1989 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/1989 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 08/07/1989 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/01/1989 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/20/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/19/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
PROPRANOLOL HYDROCHLORIDE
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 |
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; 80MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 071976 | IMPAX LABS INC |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 070322 | INNOGENIX |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 078955 | IPCA LABS LTD |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 070213 | MYLAN |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 078213 | NORTHSTAR HLTHCARE |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 070221 | VINTAGE PHARMS |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 070178 | WATSON LABS |
TABLET;ORAL; 60MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 071976 | IMPAX LABS INC |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 070322 | INNOGENIX |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 078955 | IPCA LABS LTD |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 070213 | MYLAN |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 078213 | NORTHSTAR HLTHCARE |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 070221 | VINTAGE PHARMS |