Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090270
Company: MYLAN INSTITUTIONAL
Company: MYLAN INSTITUTIONAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MELPHALAN HYDROCHLORIDE | MELPHALAN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
06/09/2009 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090270s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/27/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
07/14/2011 | SUPPL-5 | Labeling-Container/Carton Labels |
Label is not available on this site. |
MELPHALAN HYDROCHLORIDE
INJECTABLE;INJECTION; EQ 50MG BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MELPHALAN HYDROCHLORIDE | MELPHALAN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 206018 | ACTAVIS LLC |
MELPHALAN HYDROCHLORIDE | MELPHALAN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204817 | ALMAJECT |
MELPHALAN HYDROCHLORIDE | MELPHALAN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 211463 | ARTHUR GRP |
MELPHALAN HYDROCHLORIDE | MELPHALAN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 209197 | BPI LABS |
MELPHALAN HYDROCHLORIDE | MELPHALAN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203655 | DR REDDYS |
MELPHALAN HYDROCHLORIDE | MELPHALAN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203393 | FRESENIUS KABI USA |
MELPHALAN HYDROCHLORIDE | MELPHALAN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 209826 | GLAND PHARMA LTD |
MELPHALAN HYDROCHLORIDE | MELPHALAN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090303 | HIKMA |
MELPHALAN HYDROCHLORIDE | MELPHALAN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 210947 | INGENUS PHARMS LLC |
MELPHALAN HYDROCHLORIDE | MELPHALAN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 212960 | MEITHEAL |
MELPHALAN HYDROCHLORIDE | MELPHALAN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090270 | MYLAN INSTITUTIONAL |
MELPHALAN HYDROCHLORIDE | MELPHALAN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 201379 | SAGENT PHARMS INC |