Details for New Drug Application (NDA): 040564
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NDA 040564 describes DOXYLAMINE SUCCINATE, which is a drug marketed by Copley Pharm, LNK, Perrigo, Quantum Pharmics, Actavis Labs Fl Inc, Bionpharma, Endo Operations, and Mylan Pharms Inc, and is included in nine NDAs. It is available from thirty-one suppliers. Additional details are available on the DOXYLAMINE SUCCINATE profile page.
The generic ingredient in DOXYLAMINE SUCCINATE 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.
The generic ingredient in DOXYLAMINE SUCCINATE 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 040564
| Tradename: | DOXYLAMINE SUCCINATE |
| Applicant: | Lnk |
| Ingredient: | doxylamine succinate |
| Patents: | 0 |
Pharmacology for NDA: 040564
| Mechanism of Action | Histamine Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 040564
Suppliers and Packaging for NDA: 040564
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOXYLAMINE SUCCINATE | doxylamine succinate | TABLET;ORAL | 040564 | ANDA | Walgreen Company | 0363-0386 | 0363-0386-31 | 1 BOTTLE, PLASTIC in 1 CARTON (0363-0386-31) / 80 TABLET in 1 BOTTLE, PLASTIC |
| DOXYLAMINE SUCCINATE | doxylamine succinate | TABLET;ORAL | 040564 | ANDA | Better Living Brands, LLC | 21130-986 | 21130-986-27 | 2 BLISTER PACK in 1 CARTON (21130-986-27) / 16 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Aug 27, 2004 | TE: | RLD: | No | |||||
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