DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 076543
NDA 076543 describes BETAMETHASONE DIPROPIONATE, which is a drug marketed by Fougera Pharms, Glenmark Generics, Perrigo New York, Taro, Tolmar, Actavis Mid Atlantic, Pharmaderm, Teva, Teligent Pharma Inc, Alpharma Us Pharms, Fougera Pharms Inc, G And W Labs Inc, and Hi-tech Pharmacal, and is included in thirty-eight NDAs. It is available from seventeen suppliers. Additional details are available on the BETAMETHASONE DIPROPIONATE profile page.
The generic ingredient in BETAMETHASONE DIPROPIONATE is betamethasone dipropionate. There are sixty-six drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate profile page.
The generic ingredient in BETAMETHASONE DIPROPIONATE is betamethasone dipropionate. There are sixty-six drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate profile page.
Summary for 076543
| Tradename: | BETAMETHASONE DIPROPIONATE |
| Applicant: | Taro |
| Ingredient: | betamethasone dipropionate |
| Patents: | 0 |
| Therapeutic Class: | Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal) |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076543
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 076543
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BETAMETHASONE DIPROPIONATE | betamethasone dipropionate | CREAM, AUGMENTED;TOPICAL | 076543 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-1310 | N | 51672-1310-1 |
| BETAMETHASONE DIPROPIONATE | betamethasone dipropionate | CREAM, AUGMENTED;TOPICAL | 076543 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-1310 | N | 51672-1310-2 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM, AUGMENTED;TOPICAL | Strength | EQ 0.05% BASE | ||||
| Approval Date: | Dec 9, 2003 | TE: | AB | RLD: | No | ||||
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