FDA.reportPublic FDA data

Application 050748

Type
NDA
Sponsor
KING PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SYNERCIDDALFOPRISTIN; QUINUPRISTININJECTABLE;INTRAVENOUS350MG/VIAL;150MG/VIALYesYes
002SYNERCIDDALFOPRISTIN; QUINUPRISTININJECTABLE;INTRAVENOUS420MG/VIAL;180MG/VIALNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050748-001SYNERCIDDALFOPRISTIN; QUINUPRISTIN350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD1999-09-21
N050748-002SYNERCIDDALFOPRISTIN; QUINUPRISTIN420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-24

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.

Product history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-12-13 00:20 UTC2019-12N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-21bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-21782e0a99824c…
2021-12-28 21:50 UTC2021-12N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-2187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-2487673890dc5c…
2021-03-12 10:30 UTC2021-03N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-215aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-218869cabd3fbd…
2020-12-22 03:56 UTC2020-12N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-21c0c555d07b60…
2020-11-12 02:37 UTC2020-11N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-213f01610625f2…
2019-12-14 00:12 UTC2019-12N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-243f01610625f2…
2019-09-15 20:21 UTC2019-09N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-21b00525d2431f…
2019-09-15 20:21 UTC2019-09N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-24b00525d2431f…
2019-07-19 19:46 UTC2019-07N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-21ea99ee380514…
2019-07-19 19:46 UTC2019-07N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-216a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-211c564ffb4f44…
2024-02-18 07:12 UTC2024-02N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-21ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-21a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-219b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-21a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-213f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-243f0d92c62455…
2023-05-13 08:27 UTC2023-05N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-21053a50430f4f…
2023-05-13 08:27 UTC2023-05N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-24053a50430f4f…
2023-01-26 05:58 UTC2023-01N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-213bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-213a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-243a93d1ddd44b…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61570-260Synercidquinupristin and dalfopristinPfizer Laboratories Div Pfizer IncNDACurrent
61570-260Synercidquinupristin and dalfopristinPfizer Laboratories Div Pfizer IncNDACurrent
61570-260Synercidquinupristin and dalfopristinPfizer Laboratories Div Pfizer IncNDACurrent
61570-260Synercidquinupristin and dalfopristinPfizer Laboratories Div Pfizer IncNDACurrent
61570-260Synercidquinupristin and dalfopristinPfizer Laboratories Div Pfizer IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48777SUPPL2017-06-20
48754SUPPL2017-06-19
39240SUPPL2012-01-25
30434SUPPL2012-01-18
30433SUPPL2010-11-22
8169SUPPL2010-11-22
39239SUPPL2010-11-17
18166SUPPL2010-11-17
8168SUPPL2008-06-20
18165SUPPL2008-06-19
22215ORIG2001-07-18
30432ORIG1999-09-21
18164ORIG1999-09-21