FDA
- Status: approved
🇺🇸 ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE in United States
ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE (ABACAVIR, DOLUTEGRAVIR, LAMIVUDINE) regulatory status in United States.
Marketing authorisations
FDA
- Application: ANDA210391
- Marketing authorisation holder: CIPLA LIMITED
- Local brand name: ABACAVIR, DOLUTEGRAVIR, LAMIVUDINE
- Indication: TABLET
- Status: approved
FDA
- Application: ANDA217830
- Marketing authorisation holder: MACLEODS PHARMACEUTICALS LTD
- Local brand name: ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE
- Indication: TABLET
- Status: approved
FDA
- Application: ANDA218383
- Marketing authorisation holder: LUPIN LTD
- Local brand name: ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA212181
- Marketing authorisation holder: EMCURE PHARMS LTD
- Local brand name: ABACAVIR || DOLUTEGRAVIR || LAMIVUDINE
- Indication: TABLET
- Status: approved
FDA
- Application: ANDA210811
- Marketing authorisation holder: CIPLA LIMITED
- Local brand name: DOLUTEGRAVIR SODIUM AND ABACAVIR SULFATE AND LAMIVUDINE
- Indication: TABLET
- Status: approved
ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE approved in United States?
Yes. FDA has authorised it; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE in United States?
MACLEODS PHARMACEUTICALS LTD is the originator. The local marketing authorisation holder may differ — check the official source linked above.