GEMCITABINE HYDROCHLORIDE | N209604 | ACCORD HEALTHCARE INC
No patent or exclusivity listings for this strength.
Accord Healthcare's Gemcitabine Hydrochloride (NDA 209604, supplement 003) transitioned from prescription to discontinued status in the FDA Orange Book.
Old: RX
New: DISCN
Accord Healthcare's Gemcitabine Hydrochloride (NDA 209604, supplement 004) is no longer designated as a restricted distribution product.
Old: Yes
New: No
Accord Healthcare's Gemcitabine Hydrochloride (NDA 209604) transitioned from prescription to discontinued status in the FDA Orange Book.
Old: RX
New: DISCN
Accord Healthcare's Gemcitabine Hydrochloride (NDA 209604) was removed from the Reference-Listed Drug (RLD) status.
Old: Yes
New: No
Accord Healthcare's gemcitabine hydrochloride product (NDA 209604, supplement 003) was reclassified from a "Yes" to "No" status for the rs (restricted distribution) field, indicating removal or modification of restricted distribution requirements.
Old: Yes
New: No
Accord Healthcare's GEMCITABINE HYDROCHLORIDE (NDA 209604) transitioned from prescription (RX) to discontinued (DISCN) status.
Old: RX
New: DISCN
Accord Healthcare's gemcitabine hydrochloride product (NDA 209604) lost its restricted distribution status.
Old: Yes
New: No
Accord Healthcare's Gemcitabine Hydrochloride (NDA 209604, supplement 002) changed from prescription status to discontinued.
Old: RX
New: DISCN