Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018553
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INDERAL LA | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | Yes |
| INDERAL LA | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| INDERAL LA | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| INDERAL LA | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 04/19/1983 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/07/2023 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018553Orig1s048s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018553Orig1s048, s052ltr.pdf | |
| 11/07/2023 | SUPPL-48 |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018553Orig1s048s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018553Orig1s048, s052ltr.pdf | ||
| 12/21/2015 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/22/2015 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/17/2011 | SUPPL-37 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018553s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018553s037ltr.pdf | |
| 10/31/2007 | SUPPL-36 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018553s036ltr.pdf |
| 02/21/2007 | SUPPL-35 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018553s035ltr.pdf |
| 01/03/2007 | SUPPL-34 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018553s034ltr.pdf |
| 06/09/2004 | SUPPL-30 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18553slr030ltr.pdf |
| 02/06/2002 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 03/31/2000 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/22/1999 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 11/07/1997 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 04/17/1990 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/09/1990 | SUPPL-24 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/10/1989 | SUPPL-23 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/05/1989 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/1989 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/25/1989 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/08/1988 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/25/1988 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/20/1987 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/02/1986 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/27/1986 | SUPPL-15 | Manufacturing (CMC)-Formulation |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s015_INDERAL LA.pdf |
| 03/18/1987 | SUPPL-13 | Efficacy-New Dosing Regimen |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s013_INDERAL LA.pdf |
| 03/04/1986 | SUPPL-12 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s012_INDERAL LA.pdf |
| 11/20/1985 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/02/1985 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/1986 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/20/1985 | SUPPL-8 | Efficacy |
Label is not available on this site. |
||
| 03/21/1985 | SUPPL-6 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s006_INDERAL LA.pdf |
| 08/09/1984 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s005_INDERAL LA.pdf |
| 10/11/1984 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/06/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/09/1984 | SUPPL-1 | Efficacy |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/07/2023 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018553Orig1s048s052lbl.pdf | |
| 11/07/2023 | SUPPL-48 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018553Orig1s048s052lbl.pdf | |
| 03/17/2011 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018553s037lbl.pdf |
INDERAL LA
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 |
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; 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 |