Patient information: uses, side effects, how to take - Briellyn
HOW TO TAKE THE PILL:
The instructions given in the DETAILED PATIENT LABELING and BRIEF SUMMARY PATIENT PACKAGE INSERT are included inside the foil pouch. The instructions include the directions on starting the first pack on Day-One (first choice) of her period and the Sunday start (Sunday after period starts). The patient is advised that, if she used the Sunday start, she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills. The patient is also instructed as to what she should do if she misses a pill or pills. The patient is warned that she may become pregnant if she misses a pill or pills and that she should use a back-up method of birth control in the event she has intercourse any time during the seven day period following the missed pill or pills.
Instructions on how to use the blister for the (28 Tablets) are included in the BRIEF SUMMARY PATIENT PACKAGE INSERT.
About this document
Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 090538
· View the label on DailyMed
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The information on this site does not replace the advice of a doctor or pharmacist.
Drug information for Briellyn
| Rx or OTC |
Prescription (Rx)?
- This drug is available only with a prescription from a licensed healthcare provider.
- Rx
|
| Drug class |
Estrogen, Progestin |
| Active ingredients |
Norethindrone 0.4 mg,
Ethinyl estradiol 0.035 mg
|
| Dosage form |
Kit |
| Marketing status |
listed in the FDA NDC Directory |
| Company (applicant) |
GLENMARK PHARMS LTD |
| FDA approval |
ANDA 090538Abbreviated New Drug Application (ANDA) – generic drug
Approved March 22, 2011
|
| Therapeutic equivalence (TE) code |
ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book). |
| Generics |
Alyacen, Alyacen 1/35, Alyacen 7/7/7, Aranelle, Aurovela Fe, Aurovela Fe 1/20, Balziva, Blisovi 24 Fe, Blisovi Fe 1.5/30, Blisovi Fe 1/20, Charlotte 24Fe, Cyonanz
with the same TE code
|
| Manufacturers |
1 labelers list this drug on DailyMed |
| Packages (NDC) |
| Package |
|
0.4 mg, 0.035 mg – 1 in 1 blister pack / 3 in 1 carton
NDC 68462-316-29
|
|
Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.
