BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY
GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH)
GlaxoSmithKline Consumer Heatlhcare LP
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1062634 | 3003508968 | GlaxoSmithKline Consumer Heatlhcare LP | 1 | Y | 2020-04-25 | 4480 Swinnea Rd MEMPHIS TN US 38118 |
| 2950935 | 1000142582 | GLAXOSMITHKLINE CONSUMER HEALTHCARE, L.P. | 1 | Y | 2020-04-25 | 2020 E. VINE AVE. FRESNO CA US 93706 |
| 3008316718 | 3008316718 | GlaxoSmithKline Consumer Healthcare LP | 1 | Y | 2020-04-25 | 115 Willow Springs Ln York PA US 17406 |
| 3008365414 | 3008365414 | GlaxoSmithKline Consumer Healthcare LP | 1 | Y | 2020-04-25 | Rd. #1 Km 21.1 c/o Ceasar Castillo Inc. Guaynabo PR US 00970 |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 7516 | 1417949907 | K123731 | BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY | LFD | 2013-01-04 |
| 142174 | 1417949907 | K123731 | BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY | LFD | 2013-01-04 |
| 7516 | 1656416605 | K103745 | BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF | LFD | 2011-07-20 |
| 142174 | 1656416605 | K103745 | BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF | LFD | 2011-07-20 |
| 7516 | 1842604639 | K061331 | ORAL BALANCE LIQUID/ GEL | LFD | 2006-07-25 |
| 142174 | 1842604639 | K061331 | ORAL BALANCE LIQUID/ GEL | LFD | 2006-07-25 |
| 142174 | 1143669791 | ||||
| 7516 | 1268529098 | ||||
| 142174 | 1268529098 | ||||
| 7516 | 1635559116 | ||||
| 142174 | 1635559116 | ||||
| 7516 | 1795115566 | ||||
| 142174 | 1795115566 |
Product Codes Associated With Registrations
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LFD | 6 | 2013-01-04 |
PMN
BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF
GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH)
BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH
GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH)
ACTIPROTECT UC N95 RESPIRATOR
GLAXOSMITHKLINE CONSUMER HEALTHCARE
ACTIPROTECT UF N95 RESPIRATOR
GLAXOSMITHKLINE CONSUMER HEALTHCARE
ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD
GLAXOSMITHKLINE CONSUMER HEALTHCARE
OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS
GLAXOSMITHKLINE CONSUMER HEALTHCARE, L.P.
Applications
GUDID
Biotene - Biotene Oral Rinse Dry Mouth 1x8.0 oz
2023-04-14
Biotene - Biotene Oral Balance Gel 1x42g
2023-04-14
Biotene - Biotene Oral Rinse Twin Pack 2x33.8 oz
2023-04-14
Biotene - Biotene Oral Rinse 33.8 oz Twin Pack
2023-04-14
Biotene - Biotene Ecommerce Variety Pack Rinse Spray
2023-04-14
Biotene - Biotene Dry Mouth Sample 15 mL
2023-04-14
Biotene - Biotene Dry Mouth Gentle Oral Rinse 33.8 oz
2023-04-14
Biotene - Biotene Dry Mouth Gentle Oral Rinse 16 oz
2023-04-14
Biotene - Biotene Dry Mouth Oral Rinse 16 oz
2023-04-14
Biotene - Biotene Mouth Spray 1.5 oz
2023-04-14
Biotene Oral Rinse Dry Mouth - Biotene Oral Rinse Dry Mouth 33.8 oz.
2023-04-03