Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217610
Company: NOVITIUM PHARMA
Company: NOVITIUM PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 0.1% | GEL;TRANSDERMAL | Prescription | AB | No | No |
ESTRADIOL | ESTRADIOL | 0.1% (0.5GM/PACKET) | GEL;TRANSDERMAL | Prescription | AB | No | No |
ESTRADIOL | ESTRADIOL | 0.1% (0.75GM/PACKET) | GEL;TRANSDERMAL | Prescription | AB | No | No |
ESTRADIOL | ESTRADIOL | 0.1% (1GM/PACKET) | GEL;TRANSDERMAL | Prescription | AB | No | No |
ESTRADIOL | ESTRADIOL | 0.1% (1.25GM/PACKET) | GEL;TRANSDERMAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
08/24/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/13/2024 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
ESTRADIOL
GEL;TRANSDERMAL; 0.1%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 0.1% | GEL;TRANSDERMAL | Prescription | No | AB | 211783 | CHEMO RESEARCH SL |
ESTRADIOL | ESTRADIOL | 0.1% | GEL;TRANSDERMAL | Prescription | No | AB | 217610 | NOVITIUM PHARMA |
ESTRADIOL | ESTRADIOL | 0.1% | GEL;TRANSDERMAL | Prescription | No | AB | 216524 | PADAGIS ISRAEL |
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 | 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 | SOLARIS PHARMA CORP |
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 | 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 | SOLARIS PHARMA CORP |
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 | 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 | SOLARIS PHARMA CORP |
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 | 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 | SOLARIS PHARMA CORP |