FDA.reportPublic FDA data

Application 200494

Type
ANDA
Sponsor
GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORGESTIMATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORGESTIMATETABLET;ORAL-280.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGNoNo
002NORGESTIMATE; ETHINYL ESTRADIOLNORGESTIMATE; ETHINYL ESTRADIOLTABLET; ORAL0.215MG; 0.035MGNoNo
003NORGESTIMATE; ETHINYL ESTRADIOLNORGESTIMATE; ETHINYL ESTRADIOLTABLET; ORAL0.25MG; 0.035MGNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200494-001NORGESTIMATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORGESTIMATE0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-28ABRS2011-06-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A200494-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A200494-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-28ABRS2011-06-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A200494-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA8b247e46-203e-4f5b-b5a7-cbd57341c7352026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200494
application number: ANDA200494
ndc (product): 68462-565
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutions6ae97238-28cf-4bc9-a4ba-1e2bf4e3c6002023-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200494
application number: ANDA200494
ndc (product): 50090-2603
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LP4a159dcd-8af4-4e59-8f46-7b0fe5c228072022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200494
application number: ANDA200494
ndc (product): 71205-191

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-2603Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolA-S Medication SolutionsANDACurrent
53002-1733Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolRPK Pharmaceuticals, Inc.ANDACurrent
53002-1733Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolRPK Pharmaceuticals, Inc.ANDACurrent
68462-565Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-565Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-565Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-565Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-565Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68788-7302Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolPreferred Pharmaceuticals Inc.ANDACurrent
68788-7894Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolPreferred Pharmaceuticals IncANDACurrent
68788-7894Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolPreferred Pharmaceuticals IncANDACurrent
71205-191Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolProficient Rx LPANDACurrent
71205-191Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolProficient Rx LPANDACurrent
71205-191Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolProficient Rx LPANDACurrent
71205-191Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolProficient Rx LPANDACurrent