Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078065
Company: NORTEC DEV ASSOC
Company: NORTEC DEV ASSOC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 01/26/2007 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/078065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078065s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/13/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/26/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/078065lbl.pdf |
PROPRANOLOL HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| INDERAL LA | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 018553 | ANI PHARMS |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078494 | ACTAVIS ELIZABETH |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078703 | ADARE PHARMS INC |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212026 | AMTA |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078065 | NORTEC DEV ASSOC |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090321 | ZYDUS PHARMS USA INC |
CAPSULE, EXTENDED RELEASE;ORAL; 80MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| INDERAL LA | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 018553 | ANI PHARMS |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078494 | ACTAVIS ELIZABETH |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078703 | ADARE PHARMS INC |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212026 | AMTA |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078065 | NORTEC DEV ASSOC |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090321 | ZYDUS PHARMS USA INC |
CAPSULE, EXTENDED RELEASE;ORAL; 120MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| INDERAL LA | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 018553 | ANI PHARMS |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078494 | ACTAVIS ELIZABETH |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078703 | ADARE PHARMS INC |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212026 | AMTA |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078065 | NORTEC DEV ASSOC |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090321 | ZYDUS PHARMS USA INC |
CAPSULE, EXTENDED RELEASE;ORAL; 160MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| INDERAL LA | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 018553 | ANI PHARMS |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078494 | ACTAVIS ELIZABETH |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078703 | ADARE PHARMS INC |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212026 | AMTA |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078065 | NORTEC DEV ASSOC |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090321 | ZYDUS PHARMS USA INC |