GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39527
Submission : 2024-02-08
Status : Active
Type : IV
FINISHED DOSAGE FORMULATIONS
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Drug : BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Dosage Form : FILM; BUCCAL, SUBLINGUAL
Application Number : 205299
Country : US
Patented : No
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Drug : BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Dosage Form : FILM; BUCCAL, SUBLINGUAL
Application Number : 205806
Country : US
Patented : No
Drug : IBUPROFEN
Dosage Form : SUSPENSION; ORAL
Application Number : 209207
Country : US
Patented : No
Drug : IBUPROFEN
Dosage Form : SUSPENSION; ORAL
Application Number : 209204
Country : US
Patented : No
Drug : LEVETIRACETAM
Dosage Form : SOLUTION; ORAL
Application Number : 78774
Country : US
Patented : No
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Drug : BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Dosage Form : TABLET; SUBLINGUAL
Application Number : 204431
Country : US
Patented : No
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Drug : PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE
Dosage Form : FOR SOLUTION; ORAL
Application Number : 204559
Country : US
Patented : No
Drug : LACOSAMIDE
Dosage Form : SOLUTION; ORAL
Application Number : 214672
Country : US
Patented : No
Drug : LACOSAMIDE
Dosage Form : SOLUTION; ORAL
Application Number : 204839
Country : US
Patented : No
Drug : CEFTIN
Dosage Form : TABLET; ORAL
Application Number : 50605
Country : US
Patented : No
EXCIPIENTS BY APPLICATIONS
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