Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201276
Company: MYLAN INSTITUTIONAL
Company: MYLAN INSTITUTIONAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CIDOFOVIR | CIDOFOVIR | EQ 75MG BASE/ML | 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 |
---|---|---|---|---|---|---|---|
06/27/2012 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/201276Orig1s000Approv.pdf |
CIDOFOVIR
INJECTABLE;INJECTION; EQ 75MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CIDOFOVIR | CIDOFOVIR | EQ 75MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 202501 | AVET LIFESCIENCES |
CIDOFOVIR | CIDOFOVIR | EQ 75MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 201276 | MYLAN INSTITUTIONAL |