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Details for New Drug Application (NDA): 090600
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NDA 090600 describes GLYCOLAX, which is a drug marketed by Lannett Co Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the GLYCOLAX profile page.
The generic ingredient in GLYCOLAX is polyethylene glycol 3350. There are four hundred and twenty-one drug master file entries for this compound. Sixty-two suppliers are listed for this compound. Additional details are available on the polyethylene glycol 3350 profile page.
The generic ingredient in GLYCOLAX is polyethylene glycol 3350. There are four hundred and twenty-one drug master file entries for this compound. Sixty-two suppliers are listed for this compound. Additional details are available on the polyethylene glycol 3350 profile page.
Summary for 090600
| Tradename: | GLYCOLAX |
| Applicant: | Lannett Co Inc |
| Ingredient: | polyethylene glycol 3350 |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 090600
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GLYCOLAX | polyethylene glycol 3350 | FOR SOLUTION;ORAL | 090600 | ANDA | Lannett Company, Inc. | 62175-190 | 62175-190-07 | 119 g in 1 BOTTLE (62175-190-07) |
| GLYCOLAX | polyethylene glycol 3350 | FOR SOLUTION;ORAL | 090600 | ANDA | Lannett Company, Inc. | 62175-190 | 62175-190-14 | 238 g in 1 BOTTLE (62175-190-14) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | FOR SOLUTION;ORAL | Strength | 17GM/PACKET | ||||
| Approval Date: | Oct 6, 2009 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | FOR SOLUTION;ORAL | Strength | 17GM/SCOOPFUL | ||||
| Approval Date: | Oct 6, 2009 | TE: | RLD: | No | |||||
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