Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203655
Company: DR REDDYS
Company: DR REDDYS
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 | 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 |
---|---|---|---|---|---|---|---|
12/08/2017 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203655Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203655Orig1s000ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/08/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203655Orig1s000lbl.pdf |
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 |