Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040275
Company: EPIC PHARMA LLC
Company: EPIC PHARMA LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 0.5MG | TABLET;ORAL | Prescription | AB | No | No |
ESTRADIOL | ESTRADIOL | 1MG | TABLET;ORAL | Prescription | AB | No | No |
ESTRADIOL | ESTRADIOL | 2MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
12/29/1998 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40-275_Estradiol_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40275ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040275_estradiol_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/16/2024 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
01/04/2019 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
09/24/1999 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
11/01/1999 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
11/01/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/29/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40-275_Estradiol_Prntlbl.pdf |
ESTRADIOL
TABLET;ORAL; 0.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 0.5MG | TABLET;ORAL | Prescription | No | AB | 040197 | BARR LABS INC |
ESTRADIOL | ESTRADIOL | 0.5MG | TABLET;ORAL | Prescription | No | AB | 040275 | EPIC PHARMA LLC |
ESTRADIOL | ESTRADIOL | 0.5MG | TABLET;ORAL | Prescription | No | AB | 217334 | NOVITIUM PHARMA |
TABLET;ORAL; 1MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 1MG | TABLET;ORAL | Prescription | No | AB | 040197 | BARR LABS INC |
ESTRADIOL | ESTRADIOL | 1MG | TABLET;ORAL | Prescription | No | AB | 040275 | EPIC PHARMA LLC |
ESTRADIOL | ESTRADIOL | 1MG | TABLET;ORAL | Prescription | No | AB | 217334 | NOVITIUM PHARMA |
TABLET;ORAL; 2MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 2MG | TABLET;ORAL | Prescription | No | AB | 040197 | BARR LABS INC |
ESTRADIOL | ESTRADIOL | 2MG | TABLET;ORAL | Prescription | No | AB | 040275 | EPIC PHARMA LLC |
ESTRADIOL | ESTRADIOL | 2MG | TABLET;ORAL | Prescription | No | AB | 217334 | NOVITIUM PHARMA |