Home Applications 019415 Application 019415
Type NDA
Sponsor SERONO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 002 METRODIN UROFOLLITROPIN INJECTABLE;INTRAMUSCULAR 75 IU/AMP No No 003 METRODIN UROFOLLITROPIN INJECTABLE;INTRAMUSCULAR 150 IU/AMP No No 004 FERTINEX UROFOLLITROPIN INJECTABLE;SUBCUTANEOUS 150 IU/AMP No No 005 FERTINEX UROFOLLITROPIN INJECTABLE;SUBCUTANEOUS 75 IU/AMP No No
Source provenance: Browse the complete Orange Book source catalog .
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N019415-002 METRODIN 75 IU/AMP INJECTABLE / INTRAMUSCULAR 1986-09-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019415-003 METRODIN 150 IU/AMP INJECTABLE / INTRAMUSCULAR 1986-09-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019415-004 FERTINEX 150 IU/AMP INJECTABLE / SUBCUTANEOUS 1996-08-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019415-005 FERTINEX 75 IU/AMP INJECTABLE / SUBCUTANEOUS 1996-08-23 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N019415-002 METRODIN 75 IU/AMP INJECTABLE / INTRAMUSCULAR 1986-09-18 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N019415-003 METRODIN 150 IU/AMP INJECTABLE / INTRAMUSCULAR 1986-09-18 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N019415-004 FERTINEX 150 IU/AMP INJECTABLE / SUBCUTANEOUS 1996-08-23 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N019415-005 FERTINEX 75 IU/AMP INJECTABLE / SUBCUTANEOUS 1996-08-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019415-002 METRODIN 75 IU/AMP INJECTABLE / INTRAMUSCULAR 1986-09-18 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N019415-003 METRODIN 150 IU/AMP INJECTABLE / INTRAMUSCULAR 1986-09-18 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N019415-004 FERTINEX 150 IU/AMP INJECTABLE / SUBCUTANEOUS 1996-08-23 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N019415-005 FERTINEX 75 IU/AMP INJECTABLE / SUBCUTANEOUS 1996-08-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019415-002 METRODIN 75 IU/AMP INJECTABLE / INTRAMUSCULAR 1986-09-18 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N019415-003 METRODIN 150 IU/AMP INJECTABLE / INTRAMUSCULAR 1986-09-18 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N019415-004 FERTINEX 150 IU/AMP INJECTABLE / SUBCUTANEOUS 1996-08-23 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N019415-005 FERTINEX 75 IU/AMP INJECTABLE / SUBCUTANEOUS 1996-08-23 ea99ee380514…