Details for New Drug Application (NDA): 021585
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NDA 021585 describes MUCINEX D, which is a drug marketed by Rb Hlth and is included in two NDAs. It is available from six suppliers. Additional details are available on the MUCINEX D profile page.
The generic ingredient in MUCINEX D is dextromethorphan hydrobromide; guaifenesin. There are twenty-three drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin profile page.
The generic ingredient in MUCINEX D is dextromethorphan hydrobromide; guaifenesin. There are twenty-three drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin profile page.
Summary for 021585
| Tradename: | MUCINEX D |
| Applicant: | Rb Hlth |
| Ingredient: | guaifenesin; pseudoephedrine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 021585
| Mechanism of Action | Adrenergic alpha-Agonists |
| Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions |
Suppliers and Packaging for NDA: 021585
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585 | NDA | WALGREEN COMPANY | 0363-0077 | 0363-0077-18 | 1 BLISTER PACK in 1 CARTON (0363-0077-18) > 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585 | NDA | WALGREEN COMPANY | 0363-0077 | 0363-0077-36 | 2 BLISTER PACK in 1 CARTON (0363-0077-36) > 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 600MG;60MG | ||||
| Approval Date: | Jun 22, 2004 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1.2GM;120MG | ||||
| Approval Date: | Jun 22, 2004 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 021585
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Rb Hlth | MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585-002 | Jun 22, 2004 | See Plans and Pricing | See Plans and Pricing |
| Rb Hlth | MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585-002 | Jun 22, 2004 | See Plans and Pricing | See Plans and Pricing |
| Rb Hlth | MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585-001 | Jun 22, 2004 | See Plans and Pricing | See Plans and Pricing |
| Rb Hlth | MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585-001 | Jun 22, 2004 | See Plans and Pricing | See Plans and Pricing |
| Rb Hlth | MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585-001 | Jun 22, 2004 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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