ANNOVERA
- Product NDC
- 12822-0313
- 11-digit product format
- 128220313
- Labeler code
- 12822
- Product ID
- 12822-0313_90b50883-bb8c-47a1-e053-2995a90a1651
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SEGESTERONE ACETATE, ETHINYL ESTRADIOL
- Dosage form
- RING
- Route
- VAGINAL
- Labeler
- QPharma AB
- Application
- NDA209627
- Marketing category
- NDA
- Marketing start
- 2019-08-08
- Marketing end
- 0000-00-00
- Substance
- SEGESTERONE ACETATE; ETHINYL ESTRADIOL
- Active strength
- 103 mg/1; mg/1
- Pharmacologic classes
- Estrogen Receptor Agonists [MoA],Estrogen [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
Additional Listing Data#
- Finished product
- No
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ETHINYL ESTRADIOL | 17.4 mg/1 |
| SEGESTERONE ACETATE | 103 mg/1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Status |
|---|
| 12822-0313-1 | 12822031301 | 1 POUCH in 1 CARTON (12822-0313-1) / 1 RING in 1 POUCH | 1 pouch | 08-AUG-19 | Current |