Fluconazole
Fluconazole
GLENMARK
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3015176306 | 3015176306 | Glenmark Therapeutics, Inc. | 1 | N | 2020-04-25 | 750 Corporate Drive Mahwah NJ US 07430 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 224455 | 1704974162 | K170911 | NEOCERA Advanced Barrier Cream | FRO | 2017-08-22 |
| 224455 | 1411526144 | K091719 | NEOSALUS LOTION | FRO | 2009-07-30 |
| 224455 | 1453534430 | K090585 | NEOSALUS CREAM | FRO | 2009-04-02 |
| 224455 | 1796773486 | K070309 | NEOSALUS | FRO | 2008-09-12 |
| 224455 | 1238983497 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| FRO | 4 | 2017-08-22 |
NDC#
Fluconazole
Fluconazole
Fluconazole
Fluconazole
Ondansetron
Ondansetron
Ondansetron
Ondansetron
Topiramate
Topiramate
Topiramate
Topiramate
Topiramate
Topiramate
Aprepitant
Aprepitant
Fluconazole
Fluconazole
Nicardipine Hydrochloride
Nicardipine Hydrochloride
Nicardipine Hydrochloride
Nicardipine Hydrochloride
Gabapentin
Gabapentin
Gabapentin
Gabapentin
Zonisamide
Zonisamide
Zonisamide
Zonisamide
Zonisamide
Zonisamide
Triamcinolone Acetonide
Triamcinolone Acetonide
Norethindrone Acetate and Ethinyl Estradiol
Norethindrone Acetate and Ethinyl Estradiol
abiraterone acetate
abiraterone acetate
Oxcarbazepine
Oxcarbazepine
Oxcarbazepine
Oxcarbazepine
Oxcarbazepine
Oxcarbazepine
Clindamycin Hydrochloride
Clindamycin Hydrochloride
Clindamycin Hydrochloride
Clindamycin Hydrochloride
Clindamycin Hydrochloride
Clindamycin Hydrochloride
Topiramate
Topiramate
Ondansetron
Ondansetron
Ondansetron
Ondansetron
Carvedilol
Carvedilol
Carvedilol
Carvedilol
Carvedilol
Carvedilol
Carvedilol
Carvedilol
fingolimod
fingolimod
PROGESTERONE VAGINAL INSERTS
progesterone
Naproxen Sodium
Naproxen Sodium
Naproxen Sodium
Naproxen Sodium
Mupirocin
Mupirocin
Clotrimazole
Clotrimazole
Metronidazole
Metronidazole