GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34243
Submission : 2019-10-18
Status : Active
Type : IV
FINISHED DOSAGE FORMULATIONS
ISONIAZID; PYRAZINAMIDE; RIFAMPIN
Drug : RIFATER
Dosage Form : TABLET; ORAL
Application Number : 50705
Country : US
Patented : No
Drug : SYNTHROID
Dosage Form : TABLET; ORAL
Application Number : 21402
Country : US
Patented : No
Drug : MEGESTROL ACETATE
Dosage Form : TABLET; ORAL
Application Number : 72423
Country : US
Patented : No
Drug : METFORMIN HYDROCHLORIDE
Dosage Form : TABLET; ORAL
Application Number : 77880
Country : US
Patented : No
Drug : PERSANTINE
Dosage Form : TABLET; ORAL
Application Number : 12836
Country : US
Patented : No
Drug : METHERGINE
Dosage Form : TABLET; ORAL
Application Number : 6035
Country : US
Patented : No
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Drug : HAILEY 24 FE
Dosage Form : TABLET; ORAL
Application Number : 204847
Country : US
Patented : No
Drug : NICORETTE
Dosage Form : TROCHE/LOZENGE; ORAL
Application Number : 21330
Country : US
Patented : No
Drug : NICORETTE (MINT)
Dosage Form : GUM, CHEWING; BUCCAL
Application Number : 20066
Country : US
Patented : No
Drug : NICORETTE
Dosage Form : GUM, CHEWING; BUCCAL
Application Number : 20066
Country : US
Patented : Yes
EXCIPIENTS BY APPLICATIONS
Dosage Form : Cream / Lotion / Ointment, Emulsion
Grade : Topical, Oral
Category : Emulsifying Agents
Dosage Form : Cream / Lotion / Ointment, Gel, Solution
Grade : Topical, Oral
Category : API Stability Enhancers
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