Sumatriptan injection

Ingredients and appearance - Product information

Sumatriptan injection- Sumatriptan

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 60429-995
Route of Administration Subcutaneous

Active Ingredient/Active Moiety

Ingredient Name Strength
Sumatriptan succinate ( UNII: J8BDZ68989)( Sumatriptan - UNII: 8R78F6L9VO ) 6 mgin 0.5 mL

Inactive Ingredients

Ingredient Name Code
Sodium chloride ( UNII: 451W47IQ8X)
Water ( UNII: 059QF0KO0R)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA200183 USA

Labeler - Golden State Medical Supply Inc.( 603184490)

Establishment

Name ID/FEI Business Operations
Golden State Medical Supply Inc. 603184490 relabel( 60429-995), repack( 60429-995)
Includes injection site pain, stinging/burning, swelling, erythema, bruising, bleeding.
Relief is defined as the reduction of moderate or severe pain to no or mild pain after dosing without use of rescue medication.
P<0.05 versus placebo.
A successful outcome in terms of clinical disability was defined prospectively as ability to work mildly impaired or ability to work and function normally.
Includes patientsthat may have received an additional placebo injection 1 hour after the initial injection.
Includes patientsthat may have received an additional 6 mg of sumatriptan injection 1 hour after the initial injection.
P<0.05.