GLYCOPYRROLATE
GLYCOPYRROLATE
ALEMBIC LLC
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014211783 | 3014211783 | ALEMBIC LLC | 1 | N | 2026-01-01 | 627 National Ave. Mountain View CA US 94043 |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 214231 | 1401207770 | K251015 | APRO 45 Catheter and Alembic Aspiration Tubing | NRY | 2025-04-30 |
| 214231 | 2054358920 | K251014 | APRO 45 Catheter | DQY | 2025-05-01 |
| 214231 | 1966447253 | K250962 | APRO 55 Intermediate Catheter | DQY | 2025-04-29 |
| 214231 | 1928528185 | K250958 | APRO 55 Swift Catheter and Alembic Aspiration Tubing | NRY | 2025-04-28 |
| 214231 | 1211110251 | K243297 | APRO 70 Swift Catheter | QJP | 2025-01-14 |
| 214231 | 1637091555 | K243287 | APRO 70 Swift Catheter and Alembic Aspiration Tubing | NRY | 2025-02-24 |
| 214231 | 1481122904 | K234115 | APRO 55 Catheter | DQY | 2024-03-15 |
| 214231 | 1961641822 | K232971 | APRO 55 Catheter and Alembic Aspiration Tubing | NRY | 2024-02-29 |
| 214231 | 1962649989 | K230695 | APRO 70 Catheter and Alembic Aspiration Tubing | NRY | 2023-04-10 |
| 214231 | 1806921915 | K223545 | APRO 70 Catheter and Alembic Aspiration Tubing | NRY | 2023-02-17 |
| 214231 | 1370409127 | ||||
| 214231 | 1782899246 |
Product Codes Associated With Registrations
NDC
GLYCOPYRROLATE
GLYCOPYRROLATE
Metronidazole
Metronidazole
Metronidazole
Metronidazole
Pramipexole Dihydrochloride
Pramipexole Dihydrochloride
Pramipexole Dihydrochloride
Pramipexole Dihydrochloride
Pramipexole Dihydrochloride
Pramipexole Dihydrochloride
Pramipexole Dihydrochloride
Pramipexole Dihydrochloride
Pramipexole Dihydrochloride
Pramipexole Dihydrochloride
MEPROBAMATE
MEPROBAMATE
MEPROBAMATE
MEPROBAMATE
Metronidazole
Metronidazole
Theophylline
Theophylline
Theophylline
Theophylline
ROPINIROLE
ROPINIROLE
ROPINIROLE
ROPINIROLE
ROPINIROLE
ROPINIROLE
ROPINIROLE
ROPINIROLE
ROPINIROLE
ROPINIROLE
ROPINIROLE
ROPINIROLE
ROPINIROLE
ROPINIROLE
Valsartan
Valsartan
Valsartan
Valsartan
Valsartan
Valsartan
Valsartan
Valsartan
Azithromycin
Azithromycin
Azithromycin
Azithromycin
CANDESARTAN CILEXETIL
CANDESARTAN CILEXETIL
Rivastigmine Tartrate
Rivastigmine Tartrate
Rivastigmine Tartrate
Rivastigmine Tartrate
Rivastigmine Tartrate
Rivastigmine Tartrate
Rivastigmine Tartrate
Rivastigmine Tartrate
PANTOPRAZOLE SODIUM
pantoprazole sodium injection
Fenofibrate
Fenofibrate
Fenofibrate
Fenofibrate
Fenofibrate
Fenofibrate
Triamcinolone Acetonide
Triamcinolone Acetonide
Triamcinolone Acetonide
Triamcinolone Acetonide
lamotrigine
lamotrigine chewable dispersible
lamotrigine
lamotrigine chewable dispersible
PMN
APRO 55 Intermediate Catheter
Alembic, LLC
APRO 55 Swift Catheter and Alembic Aspiration Tubing
Alembic, LLC
APRO 70 Swift Catheter and Alembic Aspiration Tubing
Alembic, LLC
APRO 70 Swift Catheter
Alembic, LLC
APRO 55 Catheter
Alembic, LLC
APRO 55 Catheter and Alembic Aspiration Tubing
Alembic, LLC
APRO 70 Catheter and Alembic Aspiration Tubing
Alembic, LLC
APRO 70 Catheter and Alembic Aspiration Tubing
Alembic, LLC
Applications
GUDID
APRO 55 Swift Catheter - APRO 55 Catheter, Hoop Configuration
2025-06-30
APRO 55 Intermediate Catheter - APRO 55 Catheter, Hoop Configuration
2025-06-30
APRO 55 Swift Catheter - APRO 55 Catheter, Hoop
2025-06-30
APRO 55 Intermediate Catheter - APRO 55 Catheter, Hooped Configuration
2025-06-30
APRO 70 SwiftCatheter - FG-02133-125-AC
2025-03-04
APRO 70 Swift Catheter - FG-02133-135-AC
2025-03-04
APRO 70 Swift Catheter - FG-02133-132-IC
2025-03-04
APRO 70 Swift Catheter - FG-02133-132-AC
2025-03-04
APRO 70 Catheter - FG-01016-N32
2024-07-22
APRO 55 Catheter - APRO-55-137
2024-04-08
APRO 55 Intermediate Catheter - APRO-55IC-125
2024-04-08
APRO 55 Intermediate Catheter - APRO-55IC-137
2024-04-08
APRO 55 Catheter - APRO-55-125
2024-04-08
APRO 70 Catheter - APRO-70-132
2023-04-27
Alembic Aspiration Tubing - FG-01001
2023-04-27
APRO 70 Catheter - APRO-70-135
2023-04-27
APRO 70 Catheter - APRO-70-125
2023-04-27