Details for New Drug Application (NDA): 201094
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NDA 201094 describes GLYDO, which is a drug marketed by Sagent Pharms Inc and is included in one NDA. It is available from one supplier. Additional details are available on the GLYDO profile page.
The generic ingredient in GLYDO is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
The generic ingredient in GLYDO is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
Summary for 201094
| Tradename: | GLYDO |
| Applicant: | Sagent Pharms Inc |
| Ingredient: | lidocaine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 201094
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 201094
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GLYDO | lidocaine hydrochloride | JELLY;TOPICAL | 201094 | ANDA | Sagent Pharmaceuticals | 25021-673 | 25021-673-76 | 10 SYRINGE in 1 CARTON (25021-673-76) / 6 mL in 1 SYRINGE |
| GLYDO | lidocaine hydrochloride | JELLY;TOPICAL | 201094 | ANDA | Sagent Pharmaceuticals | 25021-673 | 25021-673-77 | 10 SYRINGE in 1 CARTON (25021-673-77) / 11 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | JELLY;TOPICAL | Strength | 2% | ||||
| Approval Date: | Apr 28, 2014 | TE: | AT | RLD: | No | ||||
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