Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206241
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 | SYSTEM;TRANSDERMAL | Prescription | AB1 | No | No |
ESTRADIOL | ESTRADIOL | 0.0375MG/24HR | SYSTEM;TRANSDERMAL | Prescription | AB1 | No | No |
ESTRADIOL | ESTRADIOL | 0.05MG/24HR | SYSTEM;TRANSDERMAL | Prescription | AB1 | No | No |
ESTRADIOL | ESTRADIOL | 0.075MG/24HR | SYSTEM;TRANSDERMAL | Prescription | AB1 | No | No |
ESTRADIOL | ESTRADIOL | 0.1MG/24HR | SYSTEM;TRANSDERMAL | Prescription | AB1 | 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 |
---|---|---|---|---|---|---|---|
12/01/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ESTRADIOL
SYSTEM;TRANSDERMAL; 0.025MG/24HR
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 0.025MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 211293 | AMNEAL |
ESTRADIOL | ESTRADIOL | 0.025MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 201675 | MYLAN TECHNOLOGIES |
ESTRADIOL | ESTRADIOL | 0.025MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 206241 | ZYDUS PHARMS |
VIVELLE-DOT | ESTRADIOL | 0.025MG/24HR | SYSTEM;TRANSDERMAL | Prescription | Yes | AB1 | 020538 | SANDOZ |
SYSTEM;TRANSDERMAL; 0.0375MG/24HR
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 0.0375MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 211293 | AMNEAL |
ESTRADIOL | ESTRADIOL | 0.0375MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 201675 | MYLAN TECHNOLOGIES |
ESTRADIOL | ESTRADIOL | 0.0375MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 206241 | ZYDUS PHARMS |
VIVELLE-DOT | ESTRADIOL | 0.0375MG/24HR | SYSTEM;TRANSDERMAL | Prescription | Yes | AB1 | 020538 | SANDOZ |
SYSTEM;TRANSDERMAL; 0.05MG/24HR
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 0.05MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 211293 | AMNEAL |
ESTRADIOL | ESTRADIOL | 0.05MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 201675 | MYLAN TECHNOLOGIES |
ESTRADIOL | ESTRADIOL | 0.05MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 206241 | ZYDUS PHARMS |
VIVELLE-DOT | ESTRADIOL | 0.05MG/24HR | SYSTEM;TRANSDERMAL | Prescription | Yes | AB1 | 020538 | SANDOZ |
SYSTEM;TRANSDERMAL; 0.075MG/24HR
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 0.075MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 211293 | AMNEAL |
ESTRADIOL | ESTRADIOL | 0.075MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 201675 | MYLAN TECHNOLOGIES |
ESTRADIOL | ESTRADIOL | 0.075MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 206241 | ZYDUS PHARMS |
VIVELLE-DOT | ESTRADIOL | 0.075MG/24HR | SYSTEM;TRANSDERMAL | Prescription | Yes | AB1 | 020538 | SANDOZ |
SYSTEM;TRANSDERMAL; 0.1MG/24HR
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 0.1MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 211293 | AMNEAL |
ESTRADIOL | ESTRADIOL | 0.1MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 201675 | MYLAN TECHNOLOGIES |
ESTRADIOL | ESTRADIOL | 0.1MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 206241 | ZYDUS PHARMS |
VIVELLE-DOT | ESTRADIOL | 0.1MG/24HR | SYSTEM;TRANSDERMAL | Prescription | Yes | AB1 | 020538 | SANDOZ |