Acebutolol Oral Capsule
- Brand(s)
- Sectral
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Reddy Pharmaceuticals, Llc (2012-01-12)
- Oldest Current Product
- 1984-12-28
- License(s)
- NDA, ANDA
- RxNORM
- ORAL CAPSULE\ACEBUTOLOL
- FDAOB
- ORAL\CAPSULE\ACEBUTOLOL HYDROCHLORIDE
- SPL Active
- ORAL\CAPSULE\ACEBUTOLOL HYDROCHLORIDE
- SPL Moiety
- ORAL\CAPSULE\ACEBUTOLOL
product(s) by strength(s)
acebutolol hydrochloride 200 mg oral capsule
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 678570700 | Sectral | NDA | Reddy Pharmaceuticals, Llc | 1984-12-28 | ACEBUTOLOL HYDROCHLORIDE | ORAL | CAPSULE | NDA018917 | 7eee95bf-0452-4d6e-9712-33403768695a |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 003781200 | ANDA | Mylan Pharmaceuticals Inc. | 1995-04-24 | ACEBUTOLOL HYDROCHLORIDE | ORAL | CAPSULE | ANDA074288 | 6bfb00a0-c057-4dfb-9ae3-e5b7d782cd24 |
| 2 | 651620669 | ANDA | Amneal Pharmaceuticals | 2009-12-01 | ACEBUTOLOL HYDROCHLORIDE | ORAL | CAPSULE | ANDA075047 | 28f8c26c-a1e1-4485-a45f-05c82f7a34b5 |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | last marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 009046173 | ANDA | Major | 2009-12-01 | ACEBUTOLOL HYDROCHLORIDE | ORAL | CAPSULE | 651620669 | ANDA075047 | b13ea512-c15c-4f5e-beff-8d4e95917999 | |
| 2 | 422910101 | ANDA | Avkare, Inc. | 2009-12-14 | ACEBUTOLOL HYDROCHLORIDE | ORAL | CAPSULE | 651620669 | ANDA075047 | cee9d238-be0f-f1ed-0002-2e990075fda4 | |
| 3 | 502680050 | ANDA | Avpak | 2009-12-01 | ACEBUTOLOL HYDROCHLORIDE | ORAL | CAPSULE | 651620669 | ANDA075047 | ff68a002-d46d-4f9f-0705-427844ea3655 | |
| 4 | 548685520 | ANDA | Physicians Total Care, Inc. | 2006-02-01 | 2012-06-30 | ACEBUTOLOL HYDROCHLORIDE | ORAL | CAPSULE | 651620669 | ANDA075047 | 201b752c-64b4-4687-acc1-3a92bfda864e |
| 5 | 636293871 | ANDA | Bryant Ranch Prepack | 2009-12-01 | ACEBUTOLOL HYDROCHLORIDE | ORAL | CAPSULE | 651620669 | ANDA075047 | 8747d9c1-2854-44af-892a-38433b2ed4cc |
acebutolol hydrochloride 400 mg oral capsule
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 678570701 | Sectral | NDA | Reddy Pharmaceuticals, Llc | 1984-12-28 | ACEBUTOLOL HYDROCHLORIDE | ORAL | CAPSULE | NDA018917 | 7eee95bf-0452-4d6e-9712-33403768695a |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 003781400 | ANDA | Mylan Pharmaceuticals Inc. | 1995-04-24 | ACEBUTOLOL HYDROCHLORIDE | ORAL | CAPSULE | ANDA074288 | 6bfb00a0-c057-4dfb-9ae3-e5b7d782cd24 |
| 2 | 651620670 | ANDA | Amneal Pharmaceuticals | 2009-12-01 | ACEBUTOLOL HYDROCHLORIDE | ORAL | CAPSULE | ANDA075047 | 28f8c26c-a1e1-4485-a45f-05c82f7a34b5 |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 422910102 | ANDA | Avkare, Inc. | 2009-12-14 | ACEBUTOLOL HYDROCHLORIDE | ORAL | CAPSULE | 651620670 | ANDA075047 | cee9d238-be0f-f1ed-0002-2e990075fda4 |
| 2 | 502680051 | ANDA | Avpak | 2009-12-01 | ACEBUTOLOL HYDROCHLORIDE | ORAL | CAPSULE | 651620670 | ANDA075047 | ff68a002-d46d-4f9f-0705-427844ea3655 |
| 3 | 548684216 | ANDA | Physicians Total Care, Inc. | 2005-04-22 | ACEBUTOLOL HYDROCHLORIDE | ORAL | CAPSULE | 651620670 | ANDA075047 | 201b752c-64b4-4687-acc1-3a92bfda864e |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA074007 | ACEBUTOLOL HYDROCHLORIDE | True | WATSON LABORATORIES INC | 1995-10-18 | ANDA074007_001, ANDA074007_002 |
| 2 | ANDA074288 | ACEBUTOLOL HYDROCHLORIDE | MYLAN PHARMACEUTICALS INC | 1995-04-24 | ANDA074288_001, ANDA074288_002 | |
| 3 | ANDA075047 | ACEBUTOLOL HYDROCHLORIDE | AMNEAL PHARMACEUTICAL | 1999-12-30 | ANDA075047_001, ANDA075047_002 | |
| 4 | NDA018917 | SECTRAL | PROMIUS PHARMA LLC | 1984-12-28 | NDA018917_001, NDA018917_003 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA074007_001 | discontinued | ACEBUTOLOL HYDROCHLORIDE (EQ 200MG BASE) | ORAL | CAPSULE | False | 1995-10-18 | ACEBUTOLOL HYDROCHLORIDE | |
| 2 | ANDA074007_002 | discontinued | ACEBUTOLOL HYDROCHLORIDE (EQ 400MG BASE) | ORAL | CAPSULE | False | 1995-10-18 | ACEBUTOLOL HYDROCHLORIDE | |
| 3 | ANDA074288_001 | RX | ACEBUTOLOL HYDROCHLORIDE (EQ 200MG BASE) | ORAL | CAPSULE | False | AB | 1995-04-24 | ACEBUTOLOL HYDROCHLORIDE |
| 4 | ANDA074288_002 | RX | ACEBUTOLOL HYDROCHLORIDE (EQ 400MG BASE) | ORAL | CAPSULE | False | AB | 1995-04-24 | ACEBUTOLOL HYDROCHLORIDE |
| 5 | ANDA075047_001 | RX | ACEBUTOLOL HYDROCHLORIDE (EQ 200MG BASE) | ORAL | CAPSULE | False | AB | 1999-12-30 | ACEBUTOLOL HYDROCHLORIDE |
| 6 | ANDA075047_002 | RX | ACEBUTOLOL HYDROCHLORIDE (EQ 400MG BASE) | ORAL | CAPSULE | False | AB | 1999-12-30 | ACEBUTOLOL HYDROCHLORIDE |
| 7 | NDA018917_001 | RX | ACEBUTOLOL HYDROCHLORIDE (EQ 200MG BASE) | ORAL | CAPSULE | False | AB | 1984-12-28 | SECTRAL |
| 8 | NDA018917_003 | RX | ACEBUTOLOL HYDROCHLORIDE (EQ 400MG BASE) | ORAL | CAPSULE | True | AB | 1984-12-28 | SECTRAL |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 201b752c-64b4-4687-acc1-3a92bfda864e (view SPL) | ACEBUTOLOL HYDROCHLORIDE CAPSULES | prescription | Human Prescription | Physicians Total Care, Inc. | relabel, repack | 2012-09-24 | 3 | 548684216, 548685520 |
| 2 | 28f8c26c-a1e1-4485-a45f-05c82f7a34b5 (view SPL) | ACEBUTOLOL HYDROCHLORIDE CAPSULES, USP | prescription | Human Prescription | Amneal Pharmaceuticals | ANALYSIS, LABEL, MANUFACTURE, PACK | 2015-03-02 | 6 | 651620669, 651620670 |
| 3 | 6bfb00a0-c057-4dfb-9ae3-e5b7d782cd24 (view SPL) | prescription | Human Prescription | Mylan Pharmaceuticals Inc. | 2012-09-19 | 7 | 003781200, 003781400 | ||
| 4 | 7eee95bf-0452-4d6e-9712-33403768695a (view SPL) | prescription | Human Prescription | Reddy Pharmaceuticals, Llc | manufacture | 2012-01-12 | 1 | 678570700, 678570701 | |
| 5 | 8747d9c1-2854-44af-892a-38433b2ed4cc (view SPL) | ACEBUTOLOL HYDROCHLORIDE CAPSULES, USP | prescription | Human Prescription | Bryant Ranch Prepack | RELABEL, REPACK | 2015-04-28 | 1000 | 636293871 |
| 6 | b13ea512-c15c-4f5e-beff-8d4e95917999 (view SPL) | ACEBUTOLOL HYDROCHLORIDE CAPSULES | prescription | Human Prescription | Major | RELABEL, REPACK | 2011-04-07 | 4 | 009046173 |
| 7 | cee9d238-be0f-f1ed-0002-2e990075fda4 (view SPL) | ACEBUTOLOL HYDROCHLORIDE CAPSULES | prescription | Human Prescription | Avkare, Inc. | 2015-07-31 | 8 | 422910101, 422910102 | |
| 8 | ff68a002-d46d-4f9f-0705-427844ea3655 (view SPL) | ACEBUTOLOL HYDROCHLORIDE CAPSULES | prescription | Human Prescription | Avpak | 2014-09-02 | 5 | 502680050, 502680051 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII