Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212128
Company: MEITHEAL
Company: MEITHEAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AZACITIDINE | AZACITIDINE | 100MG/VIAL | POWDER;INTRAVENOUS, SUBCUTANEOUS | 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 |
|---|---|---|---|---|---|---|---|
| 11/02/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
AZACITIDINE
POWDER;INTRAVENOUS, SUBCUTANEOUS; 100MG/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AZACITIDINE | AZACITIDINE | 100MG/VIAL | POWDER;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 207475 | ACCORD HLTHCARE |
| AZACITIDINE | AZACITIDINE | 100MG/VIAL | POWDER;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 208216 | ACTAVIS LLC |
| AZACITIDINE | AZACITIDINE | 100MG/VIAL | POWDER;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 209540 | CIPLA |
| AZACITIDINE | AZACITIDINE | 100MG/VIAL | POWDER;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 201537 | DR REDDYS |
| AZACITIDINE | AZACITIDINE | 100MG/VIAL | POWDER;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 209337 | EUROHLTH INTL SARL |
| AZACITIDINE | AZACITIDINE | 100MG/VIAL | POWDER;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 212128 | MEITHEAL |
| AZACITIDINE | AZACITIDINE | 100MG/VIAL | POWDER;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 204949 | MYLAN INSTITUTIONAL |
| AZACITIDINE | AZACITIDINE | 100MG/VIAL | POWDER;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 207234 | NATCO PHARMA LTD |
| AZACITIDINE | AZACITIDINE | 100MG/VIAL | POWDER;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 207518 | SHILPA MEDICARE |
| VIDAZA | AZACITIDINE | 100MG/VIAL | POWDER;INTRAVENOUS, SUBCUTANEOUS | Prescription | Yes | AP | 050794 | CELGENE |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English