Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070322
Company: INNOGENIX
Company: INNOGENIX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 80MG | 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 | 40MG | 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 |
|---|---|---|---|---|---|---|---|
| 08/04/1986 | 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 |
|---|---|---|---|---|---|
| 08/04/1998 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1994 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/1994 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/19/1991 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/26/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 09/07/1989 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/16/1988 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 12/23/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
PROPRANOLOL HYDROCHLORIDE
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 | 070221 | ENDO OPERATIONS |
| 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 | 070178 | 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 | 070221 | ENDO OPERATIONS |
| 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 | 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 | 070221 | ENDO OPERATIONS |
| 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 | 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 | 070221 | ENDO OPERATIONS |
| 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 | 070177 | 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 | 070221 | ENDO OPERATIONS |
| 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 |