FDA Product

Ergomar Sublingual

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Ergomar Sublingual

FDA Product Code

70720-120

Regulatory Information

NDC Product Code

70720-120

Application Number

ANDA087693

Marketing Category

C73584

Effective Date

December 1, 2016

Territorial Authority

USA

FDA Title

Ergomar Sublingual Tablets, 2 mg

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

5

Company Information

ManufacturerTerSera Therapeutics, LLC

DUNS Number

080226115

Active Ingredients

Ergotamine Tartrate

Quantity: 2 mg in 1 1

Code: MRU5XH3B48

Class Code: ACTIB

Crospovidone

Code: 2S7830E561

Class Code: IACT

Microcrystalline Cellulose

Code: OP1R32D61U

Class Code: IACT

Saccharin Sodium

Code: SB8ZUX40TY

Class Code: IACT

FD&C Blue NO. 1

Code: H3R47K3TBD

Class Code: IACT

Magnesium Stearate

Code: 70097M6I30

Class Code: IACT

Aluminum Oxide

Code: LMI26O6933

Class Code: IACT

D&C Yellow NO. 10

Code: 35SW5USQ3G

Class Code: IACT

Active Moieties

ERGOTAMINE

Code: PR834Q503T

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