Details for New Drug Application (NDA): 020870
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NDA 020870 describes COMBIPATCH, which is a drug marketed by Noven Pharms Inc and is included in one NDA. It is available from one supplier. Additional details are available on the COMBIPATCH profile page.
The generic ingredient in COMBIPATCH is estradiol; norethindrone acetate. There are seventy-five drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the estradiol; norethindrone acetate profile page.
The generic ingredient in COMBIPATCH is estradiol; norethindrone acetate. There are seventy-five drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the estradiol; norethindrone acetate profile page.
Summary for 020870
| Tradename: | COMBIPATCH |
| Applicant: | Noven Pharms Inc |
| Ingredient: | estradiol; norethindrone acetate |
| Patents: | 0 |
Pharmacology for NDA: 020870
| Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 020870
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COMBIPATCH | estradiol; norethindrone acetate | FILM, EXTENDED RELEASE;TRANSDERMAL | 020870 | NDA | Noven Therapeutics, LLC | 68968-0514 | 68968-0514-8 | 8 POUCH in 1 CARTON (68968-0514-8) / 1 PATCH in 1 POUCH / 3.5 d in 1 PATCH |
| COMBIPATCH | estradiol; norethindrone acetate | FILM, EXTENDED RELEASE;TRANSDERMAL | 020870 | NDA | Noven Therapeutics, LLC | 68968-0525 | 68968-0525-8 | 8 POUCH in 1 CARTON (68968-0525-8) / 1 PATCH in 1 POUCH / 3.5 d in 1 PATCH |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 0.05MG/24HR;0.14MG/24HR | ||||
| Approval Date: | Aug 7, 1998 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 0.05MG/24HR;0.25MG/24HR | ||||
| Approval Date: | Aug 7, 1998 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020870
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Noven Pharms Inc | COMBIPATCH | estradiol; norethindrone acetate | FILM, EXTENDED RELEASE;TRANSDERMAL | 020870-002 | Aug 7, 1998 | 5,474,783 | ⤷ Get Started Free |
| Noven Pharms Inc | COMBIPATCH | estradiol; norethindrone acetate | FILM, EXTENDED RELEASE;TRANSDERMAL | 020870-001 | Aug 7, 1998 | 5,474,783 | ⤷ Get Started Free |
| Noven Pharms Inc | COMBIPATCH | estradiol; norethindrone acetate | FILM, EXTENDED RELEASE;TRANSDERMAL | 020870-002 | Aug 7, 1998 | 5,958,446 | ⤷ Get Started Free |
| Noven Pharms Inc | COMBIPATCH | estradiol; norethindrone acetate | FILM, EXTENDED RELEASE;TRANSDERMAL | 020870-002 | Aug 7, 1998 | 5,656,286 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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