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Details for New Drug Application (NDA): 022362
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NDA 022362 describes WELCHOL, which is a drug marketed by Daiichi Sankyo Inc and Daiichi Sankyo and is included in four NDAs. It is available from two suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the WELCHOL profile page.
The generic ingredient in WELCHOL is colesevelam hydrochloride. There are ten drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the colesevelam hydrochloride profile page.
The generic ingredient in WELCHOL is colesevelam hydrochloride. There are ten drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the colesevelam hydrochloride profile page.
Summary for 022362
| Tradename: | WELCHOL |
| Applicant: | Daiichi Sankyo |
| Ingredient: | colesevelam hydrochloride |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 022362
| Mechanism of Action | Bile-acid Binding Activity |
Medical Subject Heading (MeSH) Categories for 022362
Suppliers and Packaging for NDA: 022362
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362 | NDA | Ohm Laboratories, Inc. | 51660-995 | 51660-995-30 | 30 PACKET in 1 CARTON (51660-995-30) > 1 POWDER, FOR SUSPENSION in 1 PACKET |
| WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362 | NDA | Daiichi Sankyo Inc. | 65597-902 | 65597-902-30 | 30 PACKET in 1 CARTON (65597-902-30) > 1 FOR SUSPENSION in 1 PACKET |
Paragraph IV (Patent) Challenges for 022362
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| WELCHOL | FOR SUSPENSION;ORAL | colesevelam hydrochloride | 022362 | 2010-04-09 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SUSPENSION;ORAL | Strength | 1.875GM/PACKET | ||||
| Approval Date: | Oct 2, 2009 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Oct 17, 2022 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 3.75GM/PACKET | ||||
| Approval Date: | Oct 2, 2009 | TE: | AB | RLD: | Yes | ||||
| Patent: | Start Trial | Patent Expiration: | Oct 17, 2022 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 022362
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Daiichi Sankyo | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-002 | Oct 2, 2009 | Start Trial | Start Trial |
| Daiichi Sankyo | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-001 | Oct 2, 2009 | Start Trial | Start Trial |
| Daiichi Sankyo | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-002 | Oct 2, 2009 | Start Trial | Start Trial |
| Daiichi Sankyo | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-002 | Oct 2, 2009 | Start Trial | Start Trial |
| Daiichi Sankyo | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-001 | Oct 2, 2009 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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