Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215698
Company: MEITHEAL
Company: MEITHEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PLERIXAFOR | PLERIXAFOR | 24MG/1.2ML (20MG/ML) | SOLUTION;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 |
---|---|---|---|---|---|---|---|
07/24/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/05/2024 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
PLERIXAFOR
SOLUTION;SUBCUTANEOUS; 24MG/1.2ML (20MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MOZOBIL | PLERIXAFOR | 24MG/1.2ML (20MG/ML) | SOLUTION;SUBCUTANEOUS | Prescription | Yes | AP | 022311 | GENZYME |
PLERIXAFOR | PLERIXAFOR | 24MG/1.2ML (20MG/ML) | SOLUTION;SUBCUTANEOUS | Prescription | No | AP | 215334 | AMNEAL |
PLERIXAFOR | PLERIXAFOR | 24MG/1.2ML (20MG/ML) | SOLUTION;SUBCUTANEOUS | Prescription | No | AP | 205182 | DR REDDYS |
PLERIXAFOR | PLERIXAFOR | 24MG/1.2ML (20MG/ML) | SOLUTION;SUBCUTANEOUS | Prescription | No | AP | 213672 | EUGIA PHARMA |
PLERIXAFOR | PLERIXAFOR | 24MG/1.2ML (20MG/ML) | SOLUTION;SUBCUTANEOUS | Prescription | No | AP | 206644 | GLAND PHARMA LTD |
PLERIXAFOR | PLERIXAFOR | 24MG/1.2ML (20MG/ML) | SOLUTION;SUBCUTANEOUS | Prescription | No | AP | 215698 | MEITHEAL |
PLERIXAFOR | PLERIXAFOR | 24MG/1.2ML (20MG/ML) | SOLUTION;SUBCUTANEOUS | Prescription | No | AP | 211901 | MSN |
PLERIXAFOR | PLERIXAFOR | 24MG/1.2ML (20MG/ML) | SOLUTION;SUBCUTANEOUS | Prescription | No | AP | 205197 | TEVA PHARMS USA INC |