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 : 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
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
Drug : FENOFIBRATE (MICRONIZED)
Dosage Form : CAPSULE; ORAL
Application Number : 90859
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 : METHYLPHENIDATE HYDROCHLORIDE
Dosage Form : CAPSULE, EXTENDED RELEASE; ORAL
Application Number : 78458
Country : US
Patented : No
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Drug : BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Dosage Form : FILM; BUCCAL, SUBLINGUAL
Application Number : 205299
Country : US
Patented : No
Drug : ESOMEPRAZOLE MAGNESIUM
Dosage Form : CAPSULE, DELAYED REL PELLETS; ORAL
Application Number : 78279
Country : US
Patented : No
ESOMEPRAZOLE MAGNESIUM; NAPROXEN
Drug : NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
Dosage Form : TABLET, DELAYED RELEASE; ORAL
Application Number : 204206
Country : US
Patented : No
Drug : COLESEVELAM HYDROCHLORIDE
Dosage Form : TABLET; ORAL
Application Number : 210889
Country : US
Patented : No
EXCIPIENTS BY APPLICATIONS
Application : Coating Systems & Additives
Excipient Details : Coating, Core-Sealing
REF. STANDARDS & IMPURITIES
Refined Bleached Shellac (1 g)
CAS Number : 9000-59-3
Quantity Per Vial : 1
Sale Unit : g
Price : $278.00
Details : Material Origin- Insect; USMCA- No; KORUS- Ye...
Monograph :
Storage :
Code/Batch No : Catalog #1600303 / F02310
Regular Bleached Shellac (100 mg)
CAS Number : 9000-59-3
Quantity Per Vial : 100
Sale Unit : mg
Price : $198.75
Details : Material Origin- Insect; USMCA- No; KORUS- No
Monograph :
Storage :
Code/Batch No : Catalog #1600314 / F02320
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