Ergomar
Ergomar® Sublingual Tablets, 2 mg (Ergotamine Tartrate Sublingual Tablets, USP)
Approved
Approval ID
1bfd4827-5123-4dbb-8f94-7b097f5bfd5c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 8, 2012
Manufacturers
FDA
Rosedale Therapeutics
DUNS: 161264622
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ergotamine Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10802-1202
Application NumberANDA087693
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ergotamine Tartrate
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateSeptember 8, 2012
FDA Product Classification
INGREDIENTS (9)
CrospovidoneInactive
Code: 68401960MK
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
PeppermintInactive
Code: V95R5KMY2B
Classification: IACT
Ergotamine TartrateActive
Quantity: 2 mg in 1 1
Code: MRU5XH3B48
Classification: ACTIB
Saccharin Sodium DihydrateInactive
Code: SB8ZUX40TY
Classification: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Aluminum OxideInactive
Code: LMI26O6933
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT