FDA — authorised 16 December 2010
- Application: NDA022574
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: SAFYRAL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Slynd in United States
FDA authorised Slynd on 16 December 2010
Marketing authorisations
FDA — authorised 28 March 2011
- Application: ANDA090114
- Marketing authorisation holder: XIROMED
- Local brand name: SYEDA
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 28 March 2011
- Application: ANDA079221
- Marketing authorisation holder: XIROMED
- Local brand name: LORYNA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 January 2013
- Application: NDA021676
- Marketing authorisation holder: BAYER HLTHCARE
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 27 May 2014
- Application: ANDA201661
- Marketing authorisation holder: LUPIN
- Local brand name: NIKKI
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 November 2014
- Application: ANDA202015
- Marketing authorisation holder: NOVAST LABS
- Local brand name: YAELA
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 26 January 2016
- Application: ANDA202016
- Marketing authorisation holder: NOVAST LABS
- Local brand name: MELAMISA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 October 2016
- Application: ANDA203594
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 October 2016
- Application: ANDA203593
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 December 2017
- Application: ANDA205948
- Marketing authorisation holder: LUPIN
- Local brand name: TYDEMY
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 February 2018
- Application: ANDA209632
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: LO-ZUMANDIMINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 March 2018
- Application: ANDA209407
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: ZUMANDIMINE
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 13 June 2018
- Application: ANDA205947
- Marketing authorisation holder: LUPIN
- Local brand name: DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 March 2019
- Application: ANDA202138
- Marketing authorisation holder: SUN PHARM
- Local brand name: KEMEYA
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 23 May 2019
- Marketing authorisation holder: EXELTIS USA INC
- Status: approved
FDA — authorised 23 May 2019
- Application: NDA211367
- Marketing authorisation holder: EXELTIS USA INC
- Local brand name: SLYND
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 July 2019
- Application: ANDA202318
- Marketing authorisation holder: SUN PHARM
- Local brand name: KYRA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 April 2022
- Application: NDA214154
- Marketing authorisation holder: MAYNE PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 29 June 2022
- Application: NDA216285
- Marketing authorisation holder: EXELTIS USA INC
- Local brand name: DROSPIRENONE
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 28 September 2023
- Application: ANDA204848
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 4 October 2023
- Application: ANDA207245
- Marketing authorisation holder: NAARI PTE
- Indication: Labeling
- Status: approved
FDA — authorised 26 December 2024
- Application: ANDA213034
- Marketing authorisation holder: HETERO LABS
- Indication: Labeling
- Status: approved
The FDA approved Slynd, a generic version of norethindrone acetate, for marketing in the United States. The approval was granted to HETERO LABS on 26 December 2024, under the standard expedited pathway. Slynd is indicated for use in the labeling, but the specific indication is not specified in the available information.
FDA — authorised 28 October 2025
- Application: ANDA218031
- Marketing authorisation holder: NOVAST LABS
- Local brand name: DROSPIRENONE AND ESTRADIOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA216936
- Marketing authorisation holder: LUPIN LTD
- Local brand name: DROSPIRENONE
- Indication: TABLET — ORAL
- Status: approved
Slynd in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Dermatology approved in United States
Frequently asked questions
Is Slynd approved in United States?
Yes. FDA authorised it on 16 December 2010; FDA authorised it on 28 March 2011; FDA authorised it on 28 March 2011.
Who is the marketing authorisation holder for Slynd in United States?
BAYER HLTHCARE holds the US marketing authorisation.