Details for New Drug Application (NDA): 021748
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NDA 021748 describes GLUMETZA, which is a drug marketed by Santarus Inc and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the GLUMETZA profile page.
The generic ingredient in GLUMETZA is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Eighty-nine suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.
The generic ingredient in GLUMETZA is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Eighty-nine suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.
Summary for 021748
| Tradename: | GLUMETZA |
| Applicant: | Santarus Inc |
| Ingredient: | metformin hydrochloride |
| Patents: | 1 |
Suppliers and Packaging for NDA: 021748
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748 | NDA | Santarus, Inc. | 68012-002 | 68012-002-13 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68012-002-13) |
| GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748 | NDA | Santarus, Inc. | 68012-003 | 68012-003-16 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68012-003-16) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
| Approval Date: | Jun 3, 2005 | TE: | AB3 | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1GM | ||||
| Approval Date: | Jun 3, 2005 | TE: | AB3 | RLD: | Yes | ||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 23, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Expired US Patents for NDA 021748
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-002 | Jun 3, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-002 | Jun 3, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-002 | Jun 3, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-001 | Jun 3, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-001 | Jun 3, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-001 | Jun 3, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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