GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11495
Submission : 1995-04-28
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12372
Submission : 1997-02-11
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12372
Submission : 1997-02-11
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11495
Submission : 1995-04-28
Status : Active
Type : IV
FINISHED DOSAGE FORMULATIONS
ISONIAZID; PYRAZINAMIDE; RIFAMPIN
Drug : RIFATER
Dosage Form : TABLET; ORAL
Application Number : 50705
Country : US
Patented : No
Drug : FETZIMA
Dosage Form : CAPSULE, EXTENDED RELEASE; ORAL
Application Number : 204168
Country : US
Patented : Yes
Drug : KADIAN
Dosage Form : CAPSULE, EXTENDED RELEASE; ORAL
Application Number : 20616
Country : US
Patented : No
OMEPRAZOLE; SODIUM BICARBONATE
Drug : OMEPRAZOLE AND SODIUM BICARBONATE
Dosage Form : CAPSULE; ORAL
Application Number : 204068
Country : US
Patented : No
Drug : DOXYCYCLINE
Dosage Form : CAPSULE; ORAL
Application Number : 209396
Country : US
Patented : No
Drug : DEXTROAMPHETAMINE SULFATE
Dosage Form : CAPSULE, EXTENDED RELEASE; ORAL
Application Number : 76137
Country : US
Patented : No
Drug : SIROLIMUS
Dosage Form : TABLET; ORAL
Application Number : 201578
Country : US
Patented : No
Drug : PROGESTERONE
Dosage Form : CAPSULE; ORAL
Application Number : 208801
Country : US
Patented : No
Drug : CYCLOSPORINE
Dosage Form : SOLUTION; ORAL
Application Number : 65054
Country : US
Patented : No
Drug : METHYLPHENIDATE HYDROCHLORIDE
Dosage Form : CAPSULE, EXTENDED RELEASE; ORAL
Application Number : 200886
Country : US
Patented : No
EXCIPIENTS BY APPLICATIONS
Application : Coating Systems & Additives
Excipient Details : Coating, Core-Sealing
REF. STANDARDS & IMPURITIES
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