Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075826
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
08/31/2001 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75826Approval.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/07/2007 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
04/03/2002 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
02/19/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/19/2002 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/19/2002 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
PROPRANOLOL HYDROCHLORIDE
INJECTABLE;INJECTION; 1MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075826 | FRESENIUS KABI USA |
PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077760 | HIKMA FARMACEUTICA |