Details for New Drug Application (NDA): 021876
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The generic ingredient in DICLEGIS is doxylamine succinate; pyridoxine hydrochloride. There are fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the doxylamine succinate; pyridoxine hydrochloride profile page.
Summary for 021876
Tradename: | DICLEGIS |
Applicant: | Duchesnay |
Ingredient: | doxylamine succinate; pyridoxine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 021876
Ingredient-type | Analogs/Derivatives Vitamin B 6 |
Mechanism of Action | Histamine Receptor Antagonists |
Suppliers and Packaging for NDA: 021876
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICLEGIS | doxylamine succinate; pyridoxine hydrochloride | TABLET, DELAYED RELEASE;ORAL | 021876 | NDA | Duchesnay USA, Inc. | 55494-100 | 55494-100-10 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-10) |
DICLEGIS | doxylamine succinate; pyridoxine hydrochloride | TABLET, DELAYED RELEASE;ORAL | 021876 | NDA | Duchesnay USA, Inc. | 55494-100 | 55494-100-99 | 12 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-99) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 10MG;10MG | ||||
Approval Date: | Apr 8, 2013 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021876
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Duchesnay | DICLEGIS | doxylamine succinate; pyridoxine hydrochloride | TABLET, DELAYED RELEASE;ORAL | 021876-001 | Apr 8, 2013 | 6,340,695 | ⤷ Subscribe |
Duchesnay | DICLEGIS | doxylamine succinate; pyridoxine hydrochloride | TABLET, DELAYED RELEASE;ORAL | 021876-001 | Apr 8, 2013 | 7,560,122 | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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