Register entry

Sage Pharmaceuticals Inc

Data as of · How to read this entry

Registered sites
2
Active NDC listings
7
Labeller names
2
Live patents
1
Countries
2
Base
United States
Authorisation

Registered operations

Active ingredient (API) manufacture1Finished drug manufacture2
Sites

Registered establishments

2
EstablishmentAddressRegistered forFEI / DUNS
SAGE PHARMACEUTICALS, INC.Registrant: Sage Pharmaceuticals Inc4F, No. 1, Wugong 5th Rd., New Taipei City, 248020, Taiwan (TWN)Finished drug manufacture3014247166656245476
Sage Products LLC3909 Three Oaks Road, Cary, Illinois (IL) 60013, United States (USA)Active ingredient (API) manufacture, Finished drug manufacture1419181054326178
Catalogue

Drug listings by form and route

7

7 active NDC listings: 6 human otc drug, 1 human prescription drug. By marketing category: OTC MONOGRAPH DRUG 5, ANDA 1, NDA 1.

Dosage formNDCs
mouthwash3
cloth2
liquid1
rinse1
RouteNDCs
buccal4
topical2
oral1
Labeller name on the listingNDCs
sage products llc5
sage products, llc2
Exclusivity

Patents and exclusivities

1
PatentProductCoversExpiry
7935093CHLORHEXIDINE GLUCONATEchlorhexidine gluconateproductOct 2027
Catalogue

Marketed products

7
BrandGeneric nameForm / routeNDC
Antiplaque solutionCETYLPYRIDINIUM CHLORIDEmouthwash, buccal53462-275OTC MONOGRAPH DRUG
Antiseptic Oral RinseCETYLPYRIDINIUM CHLORIDEmouthwash, buccal53462-175OTC MONOGRAPH DRUG
CHLORHEXIDINE GLUCONATECHLORHEXIDINE GLUCONATEcloth, topical53462-705NDA
Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATEliquid, buccal53462-003ANDA
Comfort Shield Barrierdimethiconecloth, topical53462-915OTC MONOGRAPH DRUG
CorinzCetylpyridinium Chloriderinse, oral53462-375OTC MONOGRAPH DRUG
Perox-A-Mint SolutionHYDROGEN PEROXIDEmouthwash, buccal53462-075OTC MONOGRAPH DRUG
Neighbours

Registered in the same town

3
Compare

Comparable companies in United States

Enquiry

Common questions

Is Sage Pharmaceuticals Inc FDA approved?
Sage Pharmaceuticals Inc holds 2 FDA-registered establishments across 2 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Sage Pharmaceuticals Inc's drugs manufactured?
At registered sites in Taiwan, the United States. The FDA register lists New Taipei City; Cary, IL. Registered operations: active ingredient (API) manufacture, finished drug manufacture.
What drugs does Sage Pharmaceuticals Inc make?
7 products are listed under Sage Pharmaceuticals Inc in the openFDA NDC Directory, most often as mouthwash; cloth; liquid. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.