Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202985
Company: ZYDUS PHARMS
Company: ZYDUS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ESTRADIOL | ESTRADIOL | 0.025MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB2 | No | No |
| ESTRADIOL | ESTRADIOL | 0.0375MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB2 | No | No |
| ESTRADIOL | ESTRADIOL | 0.05MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB2 | No | No |
| ESTRADIOL | ESTRADIOL | 0.06MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB2 | No | No |
| ESTRADIOL | ESTRADIOL | 0.075MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB2 | No | No |
| ESTRADIOL | ESTRADIOL | 0.1MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB2 | 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 |
|---|---|---|---|---|---|---|---|
| 03/29/2023 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/19/2024 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
ESTRADIOL
FILM, EXTENDED RELEASE;TRANSDERMAL; 0.025MG/24HR
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLIMARA | ESTRADIOL | 0.025MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | Yes | AB2 | 020375 | BAYER HLTHCARE |
| ESTRADIOL | ESTRADIOL | 0.025MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 075182 | MYLAN TECHNOLOGIES |
| ESTRADIOL | ESTRADIOL | 0.025MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 202985 | ZYDUS PHARMS |
FILM, EXTENDED RELEASE;TRANSDERMAL; 0.0375MG/24HR
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLIMARA | ESTRADIOL | 0.0375MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | Yes | AB2 | 020375 | BAYER HLTHCARE |
| ESTRADIOL | ESTRADIOL | 0.0375MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 075182 | MYLAN TECHNOLOGIES |
| ESTRADIOL | ESTRADIOL | 0.0375MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 202985 | ZYDUS PHARMS |
FILM, EXTENDED RELEASE;TRANSDERMAL; 0.05MG/24HR
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLIMARA | ESTRADIOL | 0.05MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | Yes | AB2 | 020375 | BAYER HLTHCARE |
| ESTRADIOL | ESTRADIOL | 0.05MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 075182 | MYLAN TECHNOLOGIES |
| ESTRADIOL | ESTRADIOL | 0.05MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 202985 | ZYDUS PHARMS |
FILM, EXTENDED RELEASE;TRANSDERMAL; 0.06MG/24HR
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLIMARA | ESTRADIOL | 0.06MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | Yes | AB2 | 020375 | BAYER HLTHCARE |
| ESTRADIOL | ESTRADIOL | 0.06MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 075182 | MYLAN TECHNOLOGIES |
| ESTRADIOL | ESTRADIOL | 0.06MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 202985 | ZYDUS PHARMS |
FILM, EXTENDED RELEASE;TRANSDERMAL; 0.075MG/24HR
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLIMARA | ESTRADIOL | 0.075MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | Yes | AB2 | 020375 | BAYER HLTHCARE |
| ESTRADIOL | ESTRADIOL | 0.075MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 075182 | MYLAN TECHNOLOGIES |
| ESTRADIOL | ESTRADIOL | 0.075MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 202985 | ZYDUS PHARMS |
FILM, EXTENDED RELEASE;TRANSDERMAL; 0.1MG/24HR
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLIMARA | ESTRADIOL | 0.1MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | Yes | AB2 | 020375 | BAYER HLTHCARE |
| ESTRADIOL | ESTRADIOL | 0.1MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 075182 | MYLAN TECHNOLOGIES |
| ESTRADIOL | ESTRADIOL | 0.1MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 202985 | ZYDUS PHARMS |