Drugs@FDA: FDA-Approved Drugs
Company: MYLAN TECHNOLOGIES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 0.05MG/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 |
---|---|---|---|---|---|---|---|
02/24/2000 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75233ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75233_Estradiol.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/24/2006 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
10/06/2005 | SUPPL-11 | Labeling |
Label is not available on this site. |
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03/04/2005 | SUPPL-10 | Labeling |
Label is not available on this site. |
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01/21/2005 | SUPPL-9 | Labeling |
Label is not available on this site. |
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01/06/2005 | SUPPL-7 | Labeling |
Label is not available on this site. |
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12/23/2002 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/23/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/25/2001 | SUPPL-2 | Labeling |
Label is not available on this site. |
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11/20/2000 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
ESTRADIOL
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 |
---|---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 0.05MG/24HR | FILM, EXTENDED RELEASE; TRANSDERMAL | Prescription | No | AB2 | 075233 | MYLAN TECHNOLOGIES |