Ketotifen Fumarate
- Product NDC
- 60505-6215
- 11-digit product format
- 605056215
- Labeler code
- 60505
- Product ID
- 60505-6215_48c28736-9fef-edb8-23e0-16b71d7257e5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ketotifen Fumarate
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Apotex Corp.
- Application
- ANDA077354
- Marketing category
- ANDA
- Marketing start
- 2019-08-02
- Marketing end
- 2022-10-06
- Substance
- KETOTIFEN FUMARATE
- Active strength
- 0 mg/mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 60505-6215-1 | 60505621501 | 1 BOTTLE, PLASTIC in 1 CARTON (60505-6215-1) > 5 mL in 1 BOTTLE, PLASTIC | 2019-08-02 | 2022-10-06 | No | No | Current |