Suppliers and packages for generic ingredient: COCAINE HYDROCHLORIDE
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COCAINE HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Noden Pharma | GOPRELTO | cocaine hydrochloride | SOLUTION;NASAL | 209963 | NDA | Genus Lifesciences Inc. | 64950-359-04 | 1 BOTTLE, GLASS in 1 CARTON (64950-359-04) / 4 mL in 1 BOTTLE, GLASS | 2018-01-08 |
| Noden Pharma | GOPRELTO | cocaine hydrochloride | SOLUTION;NASAL | 209963 | NDA AUTHORIZED GENERIC | Genus Lifesciences Inc. | 64950-362-04 | 1 BOTTLE, GLASS in 1 CARTON (64950-362-04) / 4 mL in 1 BOTTLE, GLASS | 2018-06-04 |
| Noden Pharma | GOPRELTO | cocaine hydrochloride | SOLUTION;NASAL | 209963 | NDA | LXO US Inc. | 70839-359-04 | 1 BOTTLE, GLASS in 1 CARTON (70839-359-04) / 4 mL in 1 BOTTLE, GLASS | 2024-02-09 |
| Noden Pharma | GOPRELTO | cocaine hydrochloride | SOLUTION;NASAL | 209963 | NDA AUTHORIZED GENERIC | LXO US INC. | 70839-362-04 | 1 BOTTLE, GLASS in 1 CARTON (70839-362-04) / 4 mL in 1 BOTTLE, GLASS | 2024-01-29 |
| Omnivium Pharms | NUMBRINO | cocaine hydrochloride | SOLUTION;NASAL | 209575 | NDA | OMNIVIUM PHARMACEUTICALS LLC. | 81665-300-02 | 1 BOTTLE, GLASS in 1 CARTON (81665-300-02) / 4 mL in 1 BOTTLE, GLASS | 2024-06-19 |
| Omnivium Pharms | NUMBRINO | cocaine hydrochloride | SOLUTION;NASAL | 209575 | NDA AUTHORIZED GENERIC | OMNIVIUM PHARMACEUTICALS LLC. | 81665-301-02 | 1 BOTTLE, GLASS in 1 CARTON (81665-301-02) / 4 mL in 1 BOTTLE, GLASS | 2023-10-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
