Application 078503

Type
ANDA
Sponsor
OSMOTICA PHARM US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETABLET, EXTENDED RELEASE;ORAL5MGNoNo
002OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETABLET, EXTENDED RELEASE;ORAL10MGNoNo
003OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETABLET, EXTENDED RELEASE;ORAL15MGNoNo

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
A078503-001OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04
A078503-002OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04
A078503-003OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078503-001AB
A078503-002AB
A078503-003AB

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 UTC2026-02A078503-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078503-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078503-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078503-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078503-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2009-02-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078503-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2009-02-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A078503-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078503-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2009-02-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078503-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2009-02-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078503-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078503-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078503-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078503-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078503-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078503-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078503-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078503-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2009-02-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078503-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2009-02-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078503-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078503-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2009-02-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078503-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2009-02-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078503-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078503-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2009-02-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078503-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2009-02-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078503-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078503-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078503-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078503-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A078503-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A078503-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078503-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078503-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2009-02-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078503-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2009-02-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078503-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078503-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078503-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078503-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078503-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2009-02-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078503-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2009-02-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078503-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-048072bd15b7f6…

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 UTC2026-02A078503-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078503-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078503-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078503-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078503-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078503-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078503-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078503-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078503-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078503-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078503-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078503-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078503-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078503-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078503-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078503-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078503-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078503-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078503-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078503-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078503-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078503-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078503-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078503-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078503-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078503-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078503-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078503-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078503-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078503-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078503-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078503-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078503-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078503-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078503-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078503-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078503-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078503-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078503-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078503-001AB18072bd15b7f6…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEAmerican Health Packaging0c71bdfb-01db-49ac-a8e9-0037df0d24af2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078503
application number: ANDA078503
ndc (product): 68084-480
ndc (product): 68084-610
oxybutynin chlorideOXYBUTYNIN CHLORIDEChartwell RX, LLCe464c8dd-5222-4a6b-b7e9-ca608a403c6e2025-12-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078503
application number: ANDA078503
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEAvKARE94471401-a516-0fe7-ec9c-447dd2bee9722025-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078503
application number: ANDA078503
ndc (product): 42291-633
ndc (product): 42291-635
ndc (product): 42291-634
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEPD-Rx Pharmaceuticals, Inc.b5653b7e-1e3b-4da3-b3a2-33318f448c672025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078503
application number: ANDA078503
ndc (product): 43063-790
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEAvPAK242b4766-bc2b-0073-d72d-1bf879bbee242025-04-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078503
application number: ANDA078503
ndc (product): 50268-628
ndc (product): 50268-627
ndc (product): 50268-629
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLC02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a2023-05-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078503
application number: ANDA078503
ndc (product): 43353-322
ndc (product): 43353-282
ndc (product): 43353-284
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDELannett Company, Inc.c5950dba-d92b-46a0-993f-af9f9ddb52bf2023-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078503
application number: ANDA078503
ndc (product): 62175-272
ndc (product): 62175-271
ndc (product): 62175-270
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLCe985e201-2fb3-4781-9790-a1a3db1ae2a12017-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078503
application number: ANDA078503
ndc (product): 43353-285

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 55 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-633Oxybutynin ChlorideOxybutynin ChlorideAvKARE, Inc.ANDACurrent
42291-633Oxybutynin ChlorideOxybutynin ChlorideAvKAREANDACurrent
42291-634Oxybutynin ChlorideOxybutynin ChlorideAvKARE, Inc.ANDACurrent
42291-634Oxybutynin ChlorideOxybutynin ChlorideAvKAREANDACurrent
42291-635Oxybutynin ChlorideOxybutynin ChlorideAvKARE, Inc.ANDACurrent
42291-635Oxybutynin ChlorideOxybutynin ChlorideAvKAREANDACurrent
43063-790Oxybutynin ChlorideOxybutynin ChloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-790Oxybutynin ChlorideOxybutynin ChloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-790Oxybutynin ChlorideOxybutynin ChloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-790Oxybutynin ChlorideOxybutynin ChloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-790Oxybutynin ChlorideOxybutynin ChloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-282Oxybutynin ChlorideOxybutynin ChlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-284Oxybutynin ChlorideOxybutynin ChlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-285Oxybutynin ChlorideOxybutynin ChlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-322Oxybutynin ChlorideOxybutynin ChlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-769Oxybutynin ChlorideOxybutynin ChlorideAphena Pharma Solutions - Tennessee, Inc.ANDACurrent
50090-4192Oxybutynin ChlorideOxybutynin ChlorideA-S Medication SolutionsANDACurrent
50090-4192Oxybutynin ChlorideOxybutynin ChlorideA-S Medication SolutionsANDACurrent
50090-4192Oxybutynin ChlorideOxybutynin ChlorideA-S Medication SolutionsANDACurrent
50268-627Oxybutynin ChlorideOxybutynin ChlorideAvPAKANDACurrent
50268-627Oxybutynin ChlorideOxybutynin ChlorideAvPAKANDACurrent
50268-628Oxybutynin ChlorideOxybutynin ChlorideAvPAKANDACurrent
50268-628Oxybutynin ChlorideOxybutynin ChlorideAvPAKANDACurrent
50268-629Oxybutynin ChlorideOxybutynin ChlorideAvPAKANDACurrent
50268-629Oxybutynin ChlorideOxybutynin ChlorideAvPAKANDACurrent
62175-270Oxybutynin ChlorideOxybutynin ChlorideLannett Company, Inc.ANDACurrent
62175-270Oxybutynin ChlorideOxybutynin ChlorideLannett Company, Inc.ANDACurrent
62175-270Oxybutynin ChlorideOxybutynin ChlorideLannett Company, Inc..ANDACurrent
62175-270Oxybutynin ChlorideOxybutynin ChlorideLannett Company, Inc.ANDACurrent
62175-271Oxybutynin ChlorideOxybutynin ChlorideLannett Company, Inc.ANDACurrent
62175-271Oxybutynin ChlorideOxybutynin ChlorideLannett Company, Inc.ANDACurrent
62175-271Oxybutynin ChlorideOxybutynin ChlorideLannett Company, Inc..ANDACurrent
62175-271Oxybutynin ChlorideOxybutynin ChlorideLannett Company, Inc.ANDACurrent
62175-272Oxybutynin ChlorideOxybutynin ChlorideLannett Company, Inc.ANDACurrent
62175-272Oxybutynin ChlorideOxybutynin ChlorideLannett Company, Inc.ANDACurrent
62175-272Oxybutynin ChlorideOxybutynin ChlorideLannett Company, Inc..ANDACurrent
62175-272Oxybutynin ChlorideOxybutynin ChlorideLannett Company, Inc.ANDACurrent
63739-548Oxybutynin ChlorideOxybutynin ChlorideMcKesson Corporation dba SKY PackagingANDACurrent
63739-548Oxybutynin ChlorideOxybutynin ChlorideMcKesson Corporation dba SKY PackagingANDACurrent
63739-548Oxybutynin ChlorideOxybutynin ChlorideMcKesson Corporation dba SKY PackagingANDACurrent
63739-548Oxybutynin ChlorideOxybutynin ChlorideMcKesson CorporationANDACurrent
68071-2013Oxybutynin ChlorideOxybutynin ChlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68084-480Oxybutynin ChlorideOxybutynin ChlorideAmerican Health PackagingANDACurrent
68084-480Oxybutynin ChlorideOxybutynin ChlorideAmerican Health PackagingANDACurrent
68084-480Oxybutynin ChlorideOxybutynin ChlorideAmerican Health PackagingANDACurrent
68084-480Oxybutynin ChlorideOxybutynin ChlorideAmerican Health PackagingANDACurrent
68084-480Oxybutynin ChlorideOxybutynin ChlorideAmerican Health PackagingANDACurrent
68084-610Oxybutynin ChlorideOxybutynin ChlorideAmerican Health PackagingANDACurrent
68084-610Oxybutynin ChlorideOxybutynin ChlorideAmerican Health PackagingANDACurrent
68084-610Oxybutynin ChlorideOxybutynin ChlorideAmerican Health PackagingANDACurrent
68084-610Oxybutynin ChlorideOxybutynin ChlorideAmerican Health PackagingANDACurrent
68084-610Oxybutynin ChlorideOxybutynin ChlorideAmerican Health PackagingANDACurrent
71335-0669Oxybutynin ChlorideOxybutynin ChlorideBryant Ranch PrepackANDACurrent
71335-0669Oxybutynin ChlorideOxybutynin ChlorideBryant Ranch PrepackANDACurrent
71335-0669Oxybutynin ChlorideOxybutynin ChlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22622ORIG2013-08-09