Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206685
Company: MYLAN TECHNOLOGIES
Company: MYLAN TECHNOLOGIES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 0.025MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB3 | No | No |
ESTRADIOL | ESTRADIOL | 0.0375MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB3 | No | No |
ESTRADIOL | ESTRADIOL | 0.05MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB3 | No | No |
ESTRADIOL | ESTRADIOL | 0.075MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB3 | No | No |
ESTRADIOL | ESTRADIOL | 0.1MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB3 | 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 |
---|---|---|---|---|---|---|---|
08/15/2018 | ORIG-1 | Approval | STANDARD |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206685Orig1s000Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206685Orig1s000ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/15/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206685Orig1s000Lbl.pdf |
ESTRADIOL
FILM, EXTENDED RELEASE;TRANSDERMAL; 0.025MG/24HR
TE Code = AB3
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 0.025MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB3 | 211396 | AMNEAL |
ESTRADIOL | ESTRADIOL | 0.025MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB3 | 206685 | MYLAN TECHNOLOGIES |
MINIVELLE | ESTRADIOL | 0.025MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | Yes | AB3 | 203752 | NOVEN |
FILM, EXTENDED RELEASE;TRANSDERMAL; 0.0375MG/24HR
TE Code = AB3
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 0.0375MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB3 | 211396 | AMNEAL |
ESTRADIOL | ESTRADIOL | 0.0375MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB3 | 206685 | MYLAN TECHNOLOGIES |
MINIVELLE | ESTRADIOL | 0.0375MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | Yes | AB3 | 203752 | NOVEN |
FILM, EXTENDED RELEASE;TRANSDERMAL; 0.05MG/24HR
TE Code = AB3
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 0.05MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB3 | 211396 | AMNEAL |
ESTRADIOL | ESTRADIOL | 0.05MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB3 | 206685 | MYLAN TECHNOLOGIES |
MINIVELLE | ESTRADIOL | 0.05MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | Yes | AB3 | 203752 | NOVEN |
FILM, EXTENDED RELEASE;TRANSDERMAL; 0.075MG/24HR
TE Code = AB3
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 0.075MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB3 | 211396 | AMNEAL |
ESTRADIOL | ESTRADIOL | 0.075MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB3 | 206685 | MYLAN TECHNOLOGIES |
MINIVELLE | ESTRADIOL | 0.075MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | Yes | AB3 | 203752 | NOVEN |
FILM, EXTENDED RELEASE;TRANSDERMAL; 0.1MG/24HR
TE Code = AB3
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 0.1MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB3 | 211396 | AMNEAL |
ESTRADIOL | ESTRADIOL | 0.1MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB3 | 206685 | MYLAN TECHNOLOGIES |
MINIVELLE | ESTRADIOL | 0.1MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | Yes | AB3 | 203752 | NOVEN |