Details for New Drug Application (NDA): 021437
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NDA 021437 describes INSPRA, which is a drug marketed by Upjohn and is included in one NDA. It is available from two suppliers. Additional details are available on the INSPRA profile page.
The generic ingredient in INSPRA is eplerenone. There are five drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the eplerenone profile page.
The generic ingredient in INSPRA is eplerenone. There are five drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the eplerenone profile page.
Summary for 021437
| Tradename: | INSPRA |
| Applicant: | Upjohn |
| Ingredient: | eplerenone |
| Patents: | 0 |
Pharmacology for NDA: 021437
| Mechanism of Action | Aldosterone Antagonists |
Suppliers and Packaging for NDA: 021437
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INSPRA | eplerenone | TABLET;ORAL | 021437 | NDA | Viatris Specialty LLC | 58151-142 | 58151-142-93 | 30 TABLET, FILM COATED in 1 BOTTLE (58151-142-93) |
| INSPRA | eplerenone | TABLET;ORAL | 021437 | NDA | Viatris Specialty LLC | 58151-143 | 58151-143-93 | 30 TABLET, FILM COATED in 1 BOTTLE (58151-143-93) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Sep 27, 2002 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Sep 27, 2002 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Sep 27, 2002 | TE: | RLD: | No | |||||
Expired US Patents for NDA 021437
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Upjohn | INSPRA | eplerenone | TABLET;ORAL | 021437-001 | Sep 27, 2002 | ⤷ Get Started Free | ⤷ Get Started Free |
| Upjohn | INSPRA | eplerenone | TABLET;ORAL | 021437-003 | Sep 27, 2002 | ⤷ Get Started Free | ⤷ Get Started Free |
| Upjohn | INSPRA | eplerenone | TABLET;ORAL | 021437-001 | Sep 27, 2002 | ⤷ Get Started Free | ⤷ Get Started Free |
| Upjohn | INSPRA | eplerenone | TABLET;ORAL | 021437-003 | Sep 27, 2002 | ⤷ Get Started Free | ⤷ Get Started Free |
| Upjohn | INSPRA | eplerenone | TABLET;ORAL | 021437-003 | Sep 27, 2002 | ⤷ Get Started Free | ⤷ Get Started Free |
| Upjohn | INSPRA | eplerenone | TABLET;ORAL | 021437-002 | Sep 27, 2002 | ⤷ Get Started Free | ⤷ Get Started Free |
| Upjohn | INSPRA | eplerenone | TABLET;ORAL | 021437-001 | Sep 27, 2002 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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