Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075047
Company: AMNEAL PHARM
Company: AMNEAL PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ACEBUTOLOL HYDROCHLORIDE | ACEBUTOLOL HYDROCHLORIDE | EQ 200MG BASE | CAPSULE;ORAL | Prescription | AB | No | Yes |
ACEBUTOLOL HYDROCHLORIDE | ACEBUTOLOL HYDROCHLORIDE | EQ 400MG BASE | CAPSULE;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/30/1999 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75047ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/075047Orig1s000BioeqR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/21/2011 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
04/06/2015 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
05/22/2007 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/22/2007 | SUPPL-4 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
05/22/2007 | SUPPL-3 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
ACEBUTOLOL HYDROCHLORIDE
CAPSULE;ORAL; EQ 200MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ACEBUTOLOL HYDROCHLORIDE | ACEBUTOLOL HYDROCHLORIDE | EQ 200MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075047 | AMNEAL PHARM |
ACEBUTOLOL HYDROCHLORIDE | ACEBUTOLOL HYDROCHLORIDE | EQ 200MG BASE | CAPSULE;ORAL | Prescription | No | AB | 074007 | ANI PHARMS |
CAPSULE;ORAL; EQ 400MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ACEBUTOLOL HYDROCHLORIDE | ACEBUTOLOL HYDROCHLORIDE | EQ 400MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075047 | AMNEAL PHARM |
ACEBUTOLOL HYDROCHLORIDE | ACEBUTOLOL HYDROCHLORIDE | EQ 400MG BASE | CAPSULE;ORAL | Prescription | No | AB | 074007 | ANI PHARMS |