Application 091448

Type
ANDA
Sponsor
TORRENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SILDENAFIL CITRATESILDENAFIL CITRATETABLET;ORALEQ 25MG BASENoNo
002SILDENAFIL CITRATESILDENAFIL CITRATETABLET;ORALEQ 50MG BASENoNo
003SILDENAFIL CITRATESILDENAFIL CITRATETABLET;ORALEQ 100MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091448-001SILDENAFIL CITRATESILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11
A091448-002SILDENAFIL CITRATESILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11
A091448-003SILDENAFIL CITRATESILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A091448-001AB
A091448-002AB
A091448-003AB

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 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-118072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091448-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091448-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091448-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091448-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091448-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091448-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091448-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091448-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091448-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091448-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091448-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091448-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091448-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091448-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091448-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091448-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091448-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091448-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091448-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091448-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091448-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091448-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091448-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091448-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091448-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091448-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091448-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091448-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091448-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091448-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091448-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091448-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091448-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091448-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091448-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091448-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091448-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091448-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091448-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091448-001AB18072bd15b7f6…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sildenafil CitrateSILDENAFILProficient Rx LP3522bdcc-8113-4562-8ca1-f3eb884beaea2026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448
ndc (product): 71205-231
SILDENAFIL CITRATESILDENAFILPD-Rx Pharmaceuticals, Inc.ace2bb56-4992-49fe-9311-535b12eea9b42026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448
ndc (product): 43063-940
SILDENAFIL CITRATESILDENAFILPD-Rx Pharmaceuticals, Inc.78c4551c-b922-43c9-9a5a-66377ea07bc22026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448
ndc (product): 43063-941
SILDENAFIL CITRATESILDENAFILRedpharm Drug52614168-3a9e-335d-e063-6394a90ac27f2026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448
SILDENAFIL CITRATESILDENAFILNuCare Pharmaceuticals, Inc.36da8e3a-d17c-e42f-e063-6394a90a1ece2026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448
SILDENAFIL CITRATESILDENAFILPreferred Pharmaceuticals Inc.5f9ff0bb-5634-437a-96eb-249b910c7e812026-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448
SILDENAFIL CITRATESILDENAFILBryant Ranch Prepacka05ab4e7-6f70-41c3-a3b7-9a2fd7a1d2d62026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448
SILDENAFIL CITRATESILDENAFILBryant Ranch Prepackedb0919d-cbf1-4968-b0eb-342aa811c2ce2026-03-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448
SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals Limitedb48630b1-5208-4d00-b56f-21701f2237582026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448
ndc (product): 13668-187
ndc (product): 13668-188
ndc (product): 13668-186
SILDENAFIL CITRATESILDENAFILNorthwind Health Company, LLCd9de0817-cac1-4ee5-e053-2a95a90a5fa72026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 61 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13668-186Sildenafil CitrateSildenafilTorrent Pharmaceuticals LANDACurrent
13668-186SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals LimitedANDACurrent
13668-186SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals LimitedANDACurrent
13668-186SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals LimitedANDACurrent
13668-186SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals LimitedANDACurrent
13668-186SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals LimitedANDACurrent
13668-186SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals LimitedANDACurrent
13668-186SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals LimitedANDACurrent
13668-186SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals LimitedANDACurrent
13668-186SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals LimitedANDACurrent
13668-187Sildenafil CitrateSildenafilTorrent Pharmaceuticals LANDACurrent
13668-187SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals LimitedANDACurrent
13668-187SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals LimitedANDACurrent
13668-187SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals LimitedANDACurrent
13668-187SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals LimitedANDACurrent
13668-187SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals LimitedANDACurrent
13668-187SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals LimitedANDACurrent
13668-187SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals LimitedANDACurrent
13668-187SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals LimitedANDACurrent
13668-187SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals LimitedANDACurrent
13668-188SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals LimitedANDACurrent
13668-188SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals LimitedANDACurrent
13668-188SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals LimitedANDACurrent
13668-188SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals LimitedANDACurrent
13668-188SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals LimitedANDACurrent
13668-188SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals LimitedANDACurrent
13668-188SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals LimitedANDACurrent
13668-188SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals LimitedANDACurrent
13668-188SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals LimitedANDACurrent
43063-940Sildenafil CitrateSildenafilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-940Sildenafil CitrateSildenafilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-940Sildenafil CitrateSildenafilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-940SILDENAFIL CITRATESILDENAFILPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-940SILDENAFIL CITRATESILDENAFILPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-940SILDENAFIL CITRATESILDENAFILPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-940SILDENAFIL CITRATESILDENAFILPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-940SILDENAFIL CITRATESILDENAFILPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-940SILDENAFIL CITRATESILDENAFILPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-940SILDENAFIL CITRATESILDENAFILPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-941Sildenafil CitrateSildenafilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-941SILDENAFIL CITRATESILDENAFILPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-941SILDENAFIL CITRATESILDENAFILPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-941SILDENAFIL CITRATESILDENAFILPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-941SILDENAFIL CITRATESILDENAFILPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-941SILDENAFIL CITRATESILDENAFILPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-941SILDENAFIL CITRATESILDENAFILPD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-937Sildenafil CitrateSildenafilmedsource pharmaceuticalsANDACurrent
50090-3493Sildenafil CitrateSildenafilA-S Medication SolutionsANDACurrent
50090-3493Sildenafil CitrateSILDENAFILA-S Medication SolutionsANDACurrent
50090-3494Sildenafil CitrateSildenafilA-S Medication SolutionsANDACurrent
50090-3495Sildenafil CitrateSildenafilA-S Medication SolutionsANDACurrent
68071-4744Sildenafil CitrateSildenafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4744Sildenafil CitrateSildenafilNuCare Pharmaceuticals,Inc.ANDACurrent
70518-1641Sildenafil CitrateSildenafilREMEDYREPACK INC.ANDACurrent
70518-1641SILDENAFIL CITRATESILDENAFILREMEDYREPACK INC.ANDACurrent
70518-1641SILDENAFIL CITRATESILDENAFILREMEDYREPACK INC.ANDACurrent
70518-1641SILDENAFIL CITRATESILDENAFILREMEDYREPACK INC.ANDACurrent
70934-903SILDENAFIL CITRATESILDENAFILDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-231Sildenafil CitrateSildenafilProficient Rx LPANDACurrent
71205-231Sildenafil CitrateSildenafilProficient Rx LPANDACurrent
71205-231Sildenafil CitrateSildenafilProficient Rx LPANDACurrent