Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022038
Company: VERTICAL PHARMS
Company: VERTICAL PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIVIGEL | ESTRADIOL | 0.1% (0.25GM/PACKET) | GEL;TRANSDERMAL | Prescription | AB | Yes | Yes |
| DIVIGEL | ESTRADIOL | 0.1% (0.5GM/PACKET) | GEL;TRANSDERMAL | Prescription | AB | Yes | Yes |
| DIVIGEL | ESTRADIOL | 0.1% (1GM/PACKET) | GEL;TRANSDERMAL | Prescription | AB | Yes | Yes |
| DIVIGEL | ESTRADIOL | 0.1% (0.75GM/PACKET) | GEL;TRANSDERMAL | Prescription | AB | Yes | Yes |
| DIVIGEL | ESTRADIOL | 0.1% (1.25GM/PACKET) | GEL;TRANSDERMAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/04/2007 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022038s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022038s000_divigel_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022038s000_SUMR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/15/2024 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022038s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022038Orig1s012ltr.pdf | |
| 05/23/2023 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022038s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022038Orig1s010ltr.pdf | |
| 12/12/2019 | SUPPL-6 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022038s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022038Orig1s005,s006ltr.pdf | |
| 12/12/2019 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022038s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022038Orig1s005,s006ltr.pdf | |
| 08/17/2018 | SUPPL-4 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022038s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022038Orig1s004ltr.pdf | |
| 11/01/2017 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022038s003lbl.pdf | |
| 05/29/2012 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022038s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022038s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/15/2024 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022038s012lbl.pdf | |
| 05/23/2023 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022038s010lbl.pdf | |
| 12/12/2019 | SUPPL-6 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022038s005s006lbl.pdf | |
| 12/12/2019 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022038s005s006lbl.pdf | |
| 08/17/2018 | SUPPL-4 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022038s004lbl.pdf | |
| 11/01/2017 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022038s003lbl.pdf | |
| 05/29/2012 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022038s002lbl.pdf | |
| 06/04/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022038lbl.pdf |
DIVIGEL
GEL;TRANSDERMAL; 0.1% (0.25GM/PACKET)
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DIVIGEL | ESTRADIOL | 0.1% (0.25GM/PACKET) | GEL;TRANSDERMAL | Prescription | Yes | AB | 022038 | VERTICAL PHARMS |
| ESTRADIOL | ESTRADIOL | 0.1% (0.25GM/PACKET) | GEL;TRANSDERMAL | Prescription | No | AB | 216055 | AMNEAL |
| ESTRADIOL | ESTRADIOL | 0.1% (0.25GM/PACKET) | GEL;TRANSDERMAL | Prescription | No | AB | 211783 | CHEMO RESEARCH SL |
| ESTRADIOL | ESTRADIOL | 0.1% (0.25GM/PACKET) | GEL;TRANSDERMAL | Prescription | No | AB | 218507 | ENCUBE |
| ESTRADIOL | ESTRADIOL | 0.1% (0.25GM/PACKET) | GEL;TRANSDERMAL | Prescription | No | AB | 217610 | NOVITIUM PHARMA |
| ESTRADIOL | ESTRADIOL | 0.1% (0.25GM/PACKET) | GEL;TRANSDERMAL | Prescription | No | AB | 216524 | PADAGIS ISRAEL |
| ESTRADIOL | ESTRADIOL | 0.1% (0.25GM/PACKET) | GEL;TRANSDERMAL | Prescription | No | AB | 217863 | QUAGEN |
GEL;TRANSDERMAL; 0.1% (0.5GM/PACKET)
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DIVIGEL | ESTRADIOL | 0.1% (0.5GM/PACKET) | GEL;TRANSDERMAL | Prescription | Yes | AB | 022038 | VERTICAL PHARMS |
| ESTRADIOL | ESTRADIOL | 0.1% (0.5GM/PACKET) | GEL;TRANSDERMAL | Prescription | No | AB | 216055 | AMNEAL |
| ESTRADIOL | ESTRADIOL | 0.1% (0.5GM/PACKET) | GEL;TRANSDERMAL | Prescription | No | AB | 211783 | CHEMO RESEARCH SL |
| ESTRADIOL | ESTRADIOL | 0.1% (0.5GM/PACKET) | GEL;TRANSDERMAL | Prescription | No | AB | 218507 | ENCUBE |
| ESTRADIOL | ESTRADIOL | 0.1% (0.5GM/PACKET) | GEL;TRANSDERMAL | Prescription | No | AB | 217610 | NOVITIUM PHARMA |
| ESTRADIOL | ESTRADIOL | 0.1% (0.5GM/PACKET) | GEL;TRANSDERMAL | Prescription | No | AB | 216524 | PADAGIS ISRAEL |
| ESTRADIOL | ESTRADIOL | 0.1% (0.5GM/PACKET) | GEL;TRANSDERMAL | Prescription | No | AB | 217863 | QUAGEN |
GEL;TRANSDERMAL; 0.1% (1GM/PACKET)
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DIVIGEL | ESTRADIOL | 0.1% (1GM/PACKET) | GEL;TRANSDERMAL | Prescription | Yes | AB | 022038 | VERTICAL PHARMS |
| ESTRADIOL | ESTRADIOL | 0.1% (1GM/PACKET) | GEL;TRANSDERMAL | Prescription | No | AB | 216055 | AMNEAL |
| ESTRADIOL | ESTRADIOL | 0.1% (1GM/PACKET) | GEL;TRANSDERMAL | Prescription | No | AB | 211783 | CHEMO RESEARCH SL |
| ESTRADIOL | ESTRADIOL | 0.1% (1GM/PACKET) | GEL;TRANSDERMAL | Prescription | No | AB | 218507 | ENCUBE |
| ESTRADIOL | ESTRADIOL | 0.1% (1GM/PACKET) | GEL;TRANSDERMAL | Prescription | No | AB | 217610 | NOVITIUM PHARMA |
| ESTRADIOL | ESTRADIOL | 0.1% (1GM/PACKET) | GEL;TRANSDERMAL | Prescription | No | AB | 216524 | PADAGIS ISRAEL |
| ESTRADIOL | ESTRADIOL | 0.1% (1GM/PACKET) | GEL;TRANSDERMAL | Prescription | No | AB | 217863 | QUAGEN |
GEL;TRANSDERMAL; 0.1% (0.75GM/PACKET)
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DIVIGEL | ESTRADIOL | 0.1% (0.75GM/PACKET) | GEL;TRANSDERMAL | Prescription | Yes | AB | 022038 | VERTICAL PHARMS |
| ESTRADIOL | ESTRADIOL | 0.1% (0.75GM/PACKET) | GEL;TRANSDERMAL | Prescription | No | AB | 216055 | AMNEAL |
| ESTRADIOL | ESTRADIOL | 0.1% (0.75GM/PACKET) | GEL;TRANSDERMAL | Prescription | No | AB | 218507 | ENCUBE |
| ESTRADIOL | ESTRADIOL | 0.1% (0.75GM/PACKET) | GEL;TRANSDERMAL | Prescription | No | AB | 217610 | NOVITIUM PHARMA |
| ESTRADIOL | ESTRADIOL | 0.1% (0.75GM/PACKET) | GEL;TRANSDERMAL | Prescription | No | AB | 216524 | PADAGIS ISRAEL |
| ESTRADIOL | ESTRADIOL | 0.1% (0.75GM/PACKET) | GEL;TRANSDERMAL | Prescription | No | AB | 217863 | QUAGEN |
GEL;TRANSDERMAL; 0.1% (1.25GM/PACKET)
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DIVIGEL | ESTRADIOL | 0.1% (1.25GM/PACKET) | GEL;TRANSDERMAL | Prescription | Yes | AB | 022038 | VERTICAL PHARMS |
| ESTRADIOL | ESTRADIOL | 0.1% (1.25GM/PACKET) | GEL;TRANSDERMAL | Prescription | No | AB | 216055 | AMNEAL |
| ESTRADIOL | ESTRADIOL | 0.1% (1.25GM/PACKET) | GEL;TRANSDERMAL | Prescription | No | AB | 218507 | ENCUBE |
| ESTRADIOL | ESTRADIOL | 0.1% (1.25GM/PACKET) | GEL;TRANSDERMAL | Prescription | No | AB | 217610 | NOVITIUM PHARMA |
| ESTRADIOL | ESTRADIOL | 0.1% (1.25GM/PACKET) | GEL;TRANSDERMAL | Prescription | No | AB | 216524 | PADAGIS ISRAEL |
| ESTRADIOL | ESTRADIOL | 0.1% (1.25GM/PACKET) | GEL;TRANSDERMAL | Prescription | No | AB | 217863 | QUAGEN |