Details for New Drug Application (NDA): 215932
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The generic ingredient in GUAIFENESIN is guaifenesin; pseudoephedrine hydrochloride. There are twenty drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the guaifenesin; pseudoephedrine hydrochloride profile page.
Summary for 215932
Tradename: | GUAIFENESIN |
Applicant: | Dr Reddys |
Ingredient: | guaifenesin |
Patents: | 0 |
Pharmacology for NDA: 215932
Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions |
Medical Subject Heading (MeSH) Categories for 215932
Suppliers and Packaging for NDA: 215932
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GUAIFENESIN | guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 215932 | ANDA | Dr. Reddy's Laboratories Inc. | 43598-008 | 43598-008-01 | 5 BLISTER PACK in 1 CARTON (43598-008-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-008-20) |
GUAIFENESIN | guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 215932 | ANDA | Dr. Reddy's Laboratories Inc. | 43598-008 | 43598-008-40 | 2 BLISTER PACK in 1 CARTON (43598-008-40) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-008-20) |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 600MG | ||||
Approval Date: | Mar 15, 2022 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1.2GM | ||||
Approval Date: | Mar 15, 2022 | TE: | RLD: | No |
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