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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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 : SEVELAMER CARBONATE
Dosage Form : TABLET; ORAL
Application Number : 206094
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 : 205806
Country : US
Patented : No
Drug : ESOMEPRAZOLE MAGNESIUM
Dosage Form : CAPSULE, DELAYED REL PELLETS; ORAL
Application Number : 78279
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 : ZIPRASIDONE HYDROCHLORIDE
Dosage Form : CAPSULE; ORAL
Application Number : 77565
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SHELLAC
Route : ORAL
CAS :
UNII : 46N107B71O
Potency Amount : 31.2
Potency Unit : MG

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SHELLAC
Route : ORAL
CAS :
UNII : 46N107B71O
Potency Amount : 34.48
Potency Unit : MG

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SHELLAC
Route : ORAL
CAS :
UNII : 46N107B71O
Potency Amount : 0.43
Potency Unit : MG

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SHELLAC
Route : ORAL
CAS :
UNII : 46N107B71O
Potency Amount : 0
Potency Unit : NA

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SHELLAC
Route : ORAL
CAS :
UNII : 46N107B71O
Potency Amount : 75.01
Potency Unit : MG

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SHELLAC
Route : ORAL
CAS :
UNII : 46N107B71O
Potency Amount : 18
Potency Unit : MG

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SHELLAC
Route : ORAL
CAS :
UNII : 46N107B71O
Potency Amount : 3.4
Potency Unit : MG

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SHELLAC
Route : ORAL
CAS :
UNII : 46N107B71O
Potency Amount : 21.44
Potency Unit : MG

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SHELLAC
Route : ORAL
CAS :
UNII : 46N107B71O
Potency Amount : 0.74
Potency Unit : MG

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SHELLAC
Route : ORAL
CAS :
UNII : 46N107B71O
Potency Amount : 213.24
Potency Unit : MG

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
EXCIPIENTS BY APPLICATIONS
Application : Coating Systems & Additives
Excipient Details : Coating, Core-Sealing
MARKET PLACE
REF. STANDARDS & IMPURITIES