Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210044
Company: AMNEAL
Company: AMNEAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FULVESTRANT | FULVESTRANT | 250MG/5ML (50MG/ML) | SOLUTION;INTRAMUSCULAR | Prescription | AO | 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 |
|---|---|---|---|---|---|---|---|
| 03/04/2019 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210044Orig1s000ltr.pdf |
FULVESTRANT
SOLUTION;INTRAMUSCULAR; 250MG/5ML (50MG/ML)
TE Code = AO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FASLODEX | FULVESTRANT | 250MG/5ML (50MG/ML) | SOLUTION;INTRAMUSCULAR | Prescription | Yes | AO | 021344 | ASTRAZENECA |
| FULVESTRANT | FULVESTRANT | 250MG/5ML (50MG/ML) | SOLUTION;INTRAMUSCULAR | Prescription | No | AO | 211689 | ACCORD HLTHCARE |
| FULVESTRANT | FULVESTRANT | 250MG/5ML (50MG/ML) | SOLUTION;INTRAMUSCULAR | Prescription | No | AO | 215077 | ALEMBIC |
| FULVESTRANT | FULVESTRANT | 250MG/5ML (50MG/ML) | SOLUTION;INTRAMUSCULAR | Prescription | No | AO | 210044 | AMNEAL |
| FULVESTRANT | FULVESTRANT | 250MG/5ML (50MG/ML) | SOLUTION;INTRAMUSCULAR | Prescription | No | AO | 211422 | CHIA TAI TIANQING |
| FULVESTRANT | FULVESTRANT | 250MG/5ML (50MG/ML) | SOLUTION;INTRAMUSCULAR | Prescription | No | AO | 209246 | DR REDDYS |
| FULVESTRANT | FULVESTRANT | 250MG/5ML (50MG/ML) | SOLUTION;INTRAMUSCULAR | Prescription | No | AO | 208811 | EUGIA PHARMA |
| FULVESTRANT | FULVESTRANT | 250MG/5ML (50MG/ML) | SOLUTION;INTRAMUSCULAR | Prescription | No | AO | 215169 | EUGIA PHARMA |
| FULVESTRANT | FULVESTRANT | 250MG/5ML (50MG/ML) | SOLUTION;INTRAMUSCULAR | Prescription | No | AO | 207754 | GLENMARK PHARMS INC |
| FULVESTRANT | FULVESTRANT | 250MG/5ML (50MG/ML) | SOLUTION;INTRAMUSCULAR | Prescription | No | AO | 209714 | HBT LABS INC |
| FULVESTRANT | FULVESTRANT | 250MG/5ML (50MG/ML) | SOLUTION;INTRAMUSCULAR | Prescription | No | AO | 214682 | JIANGSU HANSOH PHARM |
| FULVESTRANT | FULVESTRANT | 250MG/5ML (50MG/ML) | SOLUTION;INTRAMUSCULAR | Prescription | No | AO | 205871 | SAGENT PHARMS INC |
| FULVESTRANT | FULVESTRANT | 250MG/5ML (50MG/ML) | SOLUTION;INTRAMUSCULAR | Prescription | No | AO | 205935 | SANDOZ |
| FULVESTRANT | FULVESTRANT | 250MG/5ML (50MG/ML) | SOLUTION;INTRAMUSCULAR | Prescription | No | AO | 213553 | XIROMED |
| FULVESTRANT | FULVESTRANT | 250MG/5ML (50MG/ML) | SOLUTION;INTRAMUSCULAR | Prescription | No | AO | 215234 | ZYDUS PHARMS |